Listing of adverse events by frequency.
| Event | N | % |
|---|---|---|
| Contralateral SI joint pain | 20 | 11.6 |
| SI joint pain | 14 | 8.1 |
| Trochanteric bursitis | 8 | 4.7 |
| Buttock pain | 7 | 4.1 |
| Upper respiratory infection | 7 | 4.1 |
| Fall causing back pain | 6 | 3.5 |
| Pneumonia | 6 | 3.5 |
| SI joint pain | 6 | 3.5 |
| Urinary tract infection | 5 | 2.9 |
| Knee pain | 4 | 2.3 |
| Back pain | 3 | 1.7 |
| Fall causing SI joint pain | 3 | 1.7 |
| Fall causing shoulder pain | 3 | 1.7 |
| Sinusitis | 3 | 1.7 |
| Wound infection | 3 | 1.7 |
| Acute appendicitis | 2 | 1.2 |
| Avascular necrosis of hip | 2 | 1.2 |
| Basilar artery occlusion causing stroke | 2 | 1.2 |
| Bronchitis | 2 | 1.2 |
| Cataracts | 2 | 1.2 |
| Cholecystitis | 2 | 1.2 |
| Degenerative joint disease of shoulder | 2 | 1.2 |
| Facet arthropathy with low back pain | 2 | 1.2 |
| Fall causing SI joint pain | 2 | 1.2 |
| Fall causing buttock pain | 2 | 1.2 |
| Fall causing calf contusion | 2 | 1.2 |
| Fall causing contralateral SI joint pain | 2 | 1.2 |
| Fall causing hip pain | 2 | 1.2 |
| Fall causing humerus fracture | 2 | 1.2 |
| Hip pain due to osteoarthritis | 2 | 1.2 |
| Hypercalcemia | 2 | 1.2 |
| Hypercholesterolemia | 2 | 1.2 |
| Ischial tuberosity pain | 2 | 1.2 |
| Lateral epicondylitis | 2 | 1.2 |
| Low back pain of unknown cause | 2 | 1.2 |
| Lower back pain due to lumbar spine degeneration | 2 | 1.2 |
| Lumbar facet pain | 2 | 1.2 |
| Migraine headache | 2 | 1.2 |
| Motor vehicle accident | 2 | 1.2 |
| Nephrolithiasis | 2 | 1.2 |
| Postoperative iFuse neuropathy | 2 | 1.2 |
| Postoperative nausea | 2 | 1.2 |
| Rheumatoid arthritis | 2 | 1.2 |
| Abdominal and hip pain, cause unknown | 1 | 0.6 |
| Acid reflux / helicobacter infection | 1 | 0.6 |
| Acute bronchitis | 1 | 0.6 |
| Acute confusion, cause unknown | 1 | 0.6 |
| Acute sinusitis | 1 | 0.6 |
| Allergic dermatitis due to surgical tape | 1 | 0.6 |
| Allergic reaction to wound tape | 1 | 0.6 |
| Allergic rhinitis | 1 | 0.6 |
| Anaphylaxis | 1 | 0.6 |
| Ankle pain due to arthritis | 1 | 0.6 |
| Anterior thigh pain of unknown origin | 1 | 0.6 |
| Anxiety | 1 | 0.6 |
| Aortic aneurysm | 1 | 0.6 |
| Arm/leg pain due to cervical stenosis | 1 | 0.6 |
| Asymptomatic right leg weakness on physical exam | 1 | 0.6 |
| Atrial flutter | 1 | 0.6 |
| Avascular necrosis of hip (bilateral) | 1 | 0.6 |
| Back and PSIS pain unknown cause | 1 | 0.6 |
| Back and SI joint pain due to thoracolumbar intervertebral disc degeneration | 1 | 0.6 |
| Back and SI joint pain, possible piriformis syndrome | 1 | 0.6 |
| Back and contralateral SI joint pain | 1 | 0.6 |
| Back pain due to L4-5 degeneration | 1 | 0.6 |
| Back pain due to L5-S1 degeneration | 1 | 0.6 |
| Back pain due to degenerative disc disease | 1 | 0.6 |
| Back pain due to degenerative lumbar disc disease | 1 | 0.6 |
| Back pain due to degenerative lumbar scoliosis | 1 | 0.6 |
| Back pain due to disc degeneration | 1 | 0.6 |
| Back pain due to fractured pedicle screws | 1 | 0.6 |
| Back pain due to known degenerative disc disease | 1 | 0.6 |
| Back pain due to lumbar facet disorder and lumbar spondylosis | 1 | 0.6 |
| Back pain due to lumbar screw failure | 1 | 0.6 |
| Back pain due to lumbar strain | 1 | 0.6 |
| Back pain due to mild trauma | 1 | 0.6 |
| Back pain due to spondylolisthesis | 1 | 0.6 |
| Back pain due to spondylolysis and spondylolisthesis | 1 | 0.6 |
| Back pain due to trigger point injection | 1 | 0.6 |
| Back pain from L5/S1 pseudoarthrosis and screw breakage | 1 | 0.6 |
| Back pain from minor trauma resulting in thoracolumbar fusion | 1 | 0.6 |
| Back pain from severe L5/S1 disc herniation | 1 | 0.6 |
| Back pain from sneeze | 1 | 0.6 |
| Back pain possibly due to failed prior lumbar fusion | 1 | 0.6 |
| Back pain possibly due to prior L3/4 surgery | 1 | 0.6 |
| Back pain possibly related to a previous L4-L5 discectomy | 1 | 0.6 |
| Back pain related to DDD and facet arthritis | 1 | 0.6 |
| Back pain related to lumbar disc degeneration | 1 | 0.6 |
| Back pain related to prior lumbar fusion | 1 | 0.6 |
| Back/leg pain due to L4-5 stenosis and spondylolisthesis | 1 | 0.6 |
| Bacterial gastroenteritis | 1 | 0.6 |
| Bilateral SI joint pain requiring revision | 1 | 0.6 |
| Bilateral ear pain, suspected eustachian tube malfunction | 1 | 0.6 |
| Bilateral foot numbness of unknown cause | 1 | 0.6 |
| Bilateral hip labral tear on MRI | 1 | 0.6 |
| Bilateral leg neuropathic pain | 1 | 0.6 |
| Bilateral lower extremity edema | 1 | 0.6 |
| Bleeding from cervical fusion wound | 1 | 0.6 |
| Bothersome surgical pain pump | 1 | 0.6 |
| Bowel obstruction | 1 | 0.6 |
| Buttock and leg pain | 1 | 0.6 |
| Buttock pain due to lifting heavy object | 1 | 0.6 |
| Buttock pain from irritation of nerve root by disc herniation | 1 | 0.6 |
| Calf/heel pain | 1 | 0.6 |
| Car accident causing lateral epicondylitis | 1 | 0.6 |
| Cervical cancer recurrence | 1 | 0.6 |
| Cervical myelopathy | 1 | 0.6 |
| Cervical radicular pain | 1 | 0.6 |
| Cervical radiculopathy | 1 | 0.6 |
| Chest pain | 1 | 0.6 |
| Choledocholithiasis | 1 | 0.6 |
| Chondromalacia of knee | 1 | 0.6 |
| Chronic lymphocytic leukemia | 1 | 0.6 |
| Constipation | 1 | 0.6 |
| Contralateral SI joint pain requiring fusion redo | 1 | 0.6 |
| Contralateral back and buttock pain | 1 | 0.6 |
| Contralateral back pain related to prior L5/S1 fusion | 1 | 0.6 |
| Contralateral buttock pain due to PT | 1 | 0.6 |
| Contralateral buttocks pain | 1 | 0.6 |
| Contralateral calf pain | 1 | 0.6 |
| Contralateral hip/back pain | 1 | 0.6 |
| Contralateral knee pain | 1 | 0.6 |
| Contralateral knee stiffness | 1 | 0.6 |
| Contralateral leg numbness and pain | 1 | 0.6 |
| Contralateral neck/arm pain due to cervical arthritis | 1 | 0.6 |
| Corneal abrasion | 1 | 0.6 |
| Decreased ankle jerk on physical exam | 1 | 0.6 |
| Decreased sensation and strength in ipsilateral leg | 1 | 0.6 |
| Deep venous thrombosis | 1 | 0.6 |
| Deep wound infection related to SI joint fusino | 1 | 0.6 |
| Degenerative disc disease L1/L2 | 1 | 0.6 |
| Dehydration after contralateral SI joint fusion | 1 | 0.6 |
| Diabetes mellitus | 1 | 0.6 |
| Diastasis Recti | 1 | 0.6 |
| Drug addiction rehabilitation | 1 | 0.6 |
| Drug allergy | 1 | 0.6 |
| Dry mouth causing tooth decay | 1 | 0.6 |
| Eczema flare-up | 1 | 0.6 |
| Elbow pain | 1 | 0.6 |
| Elevated liver enzymes of unknown etiology | 1 | 0.6 |
| Episode of shingles | 1 | 0.6 |
| Esophageal cancer | 1 | 0.6 |
| Facet degeneration at C4-5 and C5-6 | 1 | 0.6 |
| Fall causing SI joint pain. Poor device placement. | 1 | 0.6 |
| Fall causing ankle pain | 1 | 0.6 |
| Fall causing back and sacral pain | 1 | 0.6 |
| Fall causing buttock and hip pain | 1 | 0.6 |
| Fall causing buttock, back and neck pain | 1 | 0.6 |
| Fall causing buttocks and hip pain | 1 | 0.6 |
| Fall causing contralateral SI joint and back pain | 1 | 0.6 |
| Fall causing dislocated shoulder | 1 | 0.6 |
| Fall causing foot and hand fracture | 1 | 0.6 |
| Fall causing foot fracture | 1 | 0.6 |
| Fall causing hip and back pain | 1 | 0.6 |
| Fall causing hip/leg pain | 1 | 0.6 |
| Fall causing knee meniscal injury | 1 | 0.6 |
| Fall causing knee pain | 1 | 0.6 |
| Fall causing pain in back, buttock and neck | 1 | 0.6 |
| Fall causing radial head fracture | 1 | 0.6 |
| Fall causing shoulder rotator cuff injury | 1 | 0.6 |
| Fall causing shoulder, body, hip and knee pain | 1 | 0.6 |
| Fall causing wrist fracture | 1 | 0.6 |
| Fall worsening pain related to lumbar hardware | 1 | 0.6 |
| Fatal myocardial infarction | 1 | 0.6 |
| Fatigue/generalized weakness of unknown cause | 1 | 0.6 |
| Fibromyalgia | 1 | 0.6 |
| Flexor sheath cyst on finger | 1 | 0.6 |
| Foot pain | 1 | 0.6 |
| Foot pain due to torn tendon | 1 | 0.6 |
| Gastrointestinal bleeding | 1 | 0.6 |
| Hair loss | 1 | 0.6 |
| Hammer toe | 1 | 0.6 |
| Hamstring tear | 1 | 0.6 |
| Hand arthritis | 1 | 0.6 |
| Heart failure due to ventricular septal defect | 1 | 0.6 |
| Hematuria of unknown cause | 1 | 0.6 |
| Hiatal hernia | 1 | 0.6 |
| Hip and buttock pain | 1 | 0.6 |
| Hip arthritis requiring hip replacement | 1 | 0.6 |
| Hip bursitis | 1 | 0.6 |
| Hip pain | 1 | 0.6 |
| Hip pain after hip replacement | 1 | 0.6 |
| Hip pain due to fibrosis | 1 | 0.6 |
| Hip pain due to hip joint osteoarthritis | 1 | 0.6 |
| Hip pain of unknown cause | 1 | 0.6 |
| Hip/leg pain, possible piriformis syndrome | 1 | 0.6 |
| Hypertension exacerbation due to medication non-compliance | 1 | 0.6 |
| Hypotension related to dehydration | 1 | 0.6 |
| Iliotibial band syndrome | 1 | 0.6 |
| Infection left arm related to flu shot | 1 | 0.6 |
| Infection of implanted pain pump | 1 | 0.6 |
| Inguinal pain of unknown origin | 1 | 0.6 |
| Injury from spousal physical abuse causing back pain | 1 | 0.6 |
| Intermittent contralateral hip and buttock pain | 1 | 0.6 |
| Intermittent hip and buttock swelling | 1 | 0.6 |
| Intracranial aneurysm | 1 | 0.6 |
| Intraoperative hemorrhage | 1 | 0.6 |
| Ipisilateral thigh pain | 1 | 0.6 |
| Ipsilateral buttock pain | 1 | 0.6 |
| Ipsilateral buttocks pain | 1 | 0.6 |
| Ipsilateral hip pain | 1 | 0.6 |
| Ipsilateral knee pain due to patellofemoral arthritis | 1 | 0.6 |
| Ipsilateral leg numbness possibly due to degenerative disc disease | 1 | 0.6 |
| Ipsilateral leg pain due to prior lumbar fusion | 1 | 0.6 |
| Jaw osteomyelitis | 1 | 0.6 |
| Knee pain due to twisting injury | 1 | 0.6 |
| Knee swelling of unknown cause | 1 | 0.6 |
| L3-4 vertebral fractures due to coughing | 1 | 0.6 |
| L5 radiculopathy due to lumbar disc bulge | 1 | 0.6 |
| L5 sensory neuropathy | 1 | 0.6 |
| Lateral thigh pain unknown cause | 1 | 0.6 |
| Left groin pain related to ”left groin pull” | 1 | 0.6 |
| Leg cellulitis | 1 | 0.6 |
| Leg edema due to pneumonia hospitalization | 1 | 0.6 |
| Leg numbness possibly related to OR positioning | 1 | 0.6 |
| Leg pain | 1 | 0.6 |
| Leg pain due to piriformis syndrome | 1 | 0.6 |
| Leg pain due to possible disc bulge | 1 | 0.6 |
| Leg pain possibly due to hip osteoarthritis or lumbar disc | 1 | 0.6 |
| Leg sensory exam deficit related to epidural stimulator | 1 | 0.6 |
| Leg weakness of unknown cause | 1 | 0.6 |
| Limited knee extension related to old injury | 1 | 0.6 |
| Loosening of wrist implants after wrist fusion surgery | 1 | 0.6 |
| Loss of balance causing fall | 1 | 0.6 |
| Loss of consciousness due to supraventricular tachycardia | 1 | 0.6 |
| Low back and buttock pain | 1 | 0.6 |
| Low back and hip pain | 1 | 0.6 |
| Low back and radicular pain possibly due to prior lumbar fusion | 1 | 0.6 |
| Low back due to degenerative disc disease, spinal stenosis and SI joint dysfunction | 1 | 0.6 |
| Low back pain | 1 | 0.6 |
| Low back pain due to degenerative disc disease (location not known) | 1 | 0.6 |
| Low back pain due to facet arthritis | 1 | 0.6 |
| Low back pain due to previously implanted hardware (not iFuse) | 1 | 0.6 |
| Low back pain related to prior lumbar fusion | 1 | 0.6 |
| Low back possibly related to mild disc bulge | 1 | 0.6 |
| Lower back pain due to DDD and annular tear | 1 | 0.6 |
| Lower back pain due to L5 disc degeneration | 1 | 0.6 |
| Lower back pain due to lumbar spinal stenosis | 1 | 0.6 |
| Lumbar myofascial pain | 1 | 0.6 |
| Lumbar radiculitis, with multiple potential causes | 1 | 0.6 |
| Lumbar radiculopathy | 1 | 0.6 |
| Lung cancer diagnosis | 1 | 0.6 |
| MVA causing back and neck pain | 1 | 0.6 |
| Medication side effect | 1 | 0.6 |
| Mid and low back pain related to prior lumbar fusion | 1 | 0.6 |
| Midback pain due to thoracic degenerative disc disease and T8/9 herniation | 1 | 0.6 |
| Morbid obesity | 1 | 0.6 |
| Motor vehicle accident causing elbow pain | 1 | 0.6 |
| Motor vehicle accident causing loss of consciousness | 1 | 0.6 |
| Muscle spasms of unknown etiology | 1 | 0.6 |
| Musculoskeletal chest pain | 1 | 0.6 |
| Narcotic-induced constipation related to surgery for esophageal cancer | 1 | 0.6 |
| Nausea/vomiting/constipation related to esophageal cancer and opioid use | 1 | 0.6 |
| Neck and back pain secondary to nausea and vomiting | 1 | 0.6 |
| Neck and upper/lower back pain | 1 | 0.6 |
| Neck pain due to cervical facet arthropathy / fall | 1 | 0.6 |
| Neck pain due to cervical stenosis | 1 | 0.6 |
| Neck pain due to herniated C5-6 | 1 | 0.6 |
| Neck pain from cervical spondylosis | 1 | 0.6 |
| Neck pain possibly due to cervical stenosis | 1 | 0.6 |
| Neck pain related to cervical ACDF | 1 | 0.6 |
| Neck pain related to prior cervical fusion | 1 | 0.6 |
| Numbness around surgical wound | 1 | 0.6 |
| Numbness/tingling in foot | 1 | 0.6 |
| Osteoarthritis of wrist | 1 | 0.6 |
| Osteopenia | 1 | 0.6 |
| Osteoporosis | 1 | 0.6 |
| Osteoporotic vertebral body compression fracture | 1 | 0.6 |
| Painful diabetic neuropathy | 1 | 0.6 |
| Pericarditis | 1 | 0.6 |
| Piriformis syndrome | 1 | 0.6 |
| Possible hip pain | 1 | 0.6 |
| Postoperative iFuse neuropathy after contralateral SI joint fusion redo | 1 | 0.6 |
| Postoperative ileus | 1 | 0.6 |
| Postoperative nausea/vomiting | 1 | 0.6 |
| Postsurgical wound infection (not iFuse) | 1 | 0.6 |
| Prolapsing hemorrhoids | 1 | 0.6 |
| Pulmonary embolism | 1 | 0.6 |
| Pulmonary embolism and pneumonia | 1 | 0.6 |
| Radicular pain due to lumbar stenosis and previous lumbar surg-eries | 1 | 0.6 |
| Radicular pain due to spinal stenosis | 1 | 0.6 |
| Radicular pain from L5/S1 degeneration | 1 | 0.6 |
| Radiculopathy due to L4-S1 foraminal stenosis | 1 | 0.6 |
| Radiculopathy due to L4/5 disc degeneration | 1 | 0.6 |
| Restless leg syndrome | 1 | 0.6 |
| Right L5 radicular pain and numbness | 1 | 0.6 |
| Right foot weakness due to nerve injury from regional anesthesia | 1 | 0.6 |
| Right knee buckling | 1 | 0.6 |
| Rotator cuff pain | 1 | 0.6 |
| Rotator cuff tear | 1 | 0.6 |
| SI joint and leg pain | 1 | 0.6 |
| SI joint pain due to inadequate placement | 1 | 0.6 |
| SI joint pain, possibly from periosteal growth around implant | 1 | 0.6 |
| SI joint pain due to inadequate stabilization | 1 | 0.6 |
| SI joint pain due to radiolucency around implant | 1 | 0.6 |
| SI joint pain from irritation of SI joint implant by screw placed during lumbar fusion | 1 | 0.6 |
| Scapular pain due to cervical radiculopathy/stenosis | 1 | 0.6 |
| Scapular pain due to prior thoracolumbar fusion | 1 | 0.6 |
| Shoulder injury due to pulling | 1 | 0.6 |
| Shoulder labral tear | 1 | 0.6 |
| Shoulder pain due to bone spur | 1 | 0.6 |
| Shoulder pain of unknown etiology | 1 | 0.6 |
| Sinus tachycardia related to WPW syndrome | 1 | 0.6 |
| Sinus tachycardia, unknown cause | 1 | 0.6 |
| Spontaneous abortion | 1 | 0.6 |
| Staple irritation | 1 | 0.6 |
| Suicide | 1 | 0.6 |
| Supraspinatus tear | 1 | 0.6 |
| Symptomatic cervical stenosis | 1 | 0.6 |
| Symptomatic renal calculus | 1 | 0.6 |
| Syncope/dizziness | 1 | 0.6 |
| Systemic viral infection | 1 | 0.6 |
| Tachycardia | 1 | 0.6 |
| Thigh and foot numbness due to contralateral SI joint dysfunction | 1 | 0.6 |
| Thigh numbness due to lumbar radiculopathy | 1 | 0.6 |
| Thigh pain related to DDD | 1 | 0.6 |
| Thoracic strain | 1 | 0.6 |
| Thoracolumbar numbness related to syringomyelia | 1 | 0.6 |
| Thumb laceration | 1 | 0.6 |
| Thumb pain due to arthritis | 1 | 0.6 |
| Tibial plateau stress fracture | 1 | 0.6 |
| Transient WBC elevation without infection | 1 | 0.6 |
| Transient ischemic attack | 1 | 0.6 |
| Trauma causing leg, hip and groin pain | 1 | 0.6 |
| Trauma to finger | 1 | 0.6 |
| Twisted foot | 1 | 0.6 |
| Type 2 diabetes mellitus | 1 | 0.6 |
| Unclear, SI joint degeneration vs. pain | 1 | 0.6 |
| Upper back pain due to thoracic disc degeneration | 1 | 0.6 |
| Urge incontinence | 1 | 0.6 |
| Urinary retention | 1 | 0.6 |
| Worsened aortic atherosclerosis found during lumbar fusion surgery | 1 | 0.6 |
| Worsened cervical myelopathy | 1 | 0.6 |
| Worsened chronic thoracic pain | 1 | 0.6 |
| Worsened contralateral SI joint pain | 1 | 0.6 |
| Worsened left ankle dorsiflexion | 1 | 0.6 |
| Worsening back pain due to known degeneration of L4-L5 | 1 | 0.6 |
| Worsening fibromyalgia | 1 | 0.6 |
| Worsening lumbar radicular pain | 1 | 0.6 |
| Wound drainage | 1 | 0.6 |
| Wound infection after cervical fusion surgery | 1 | 0.6 |
| Wound seroma | 1 | 0.6 |
| Wrist injury from trauma | 1 | 0.6 |
| Xanax withdrawal | 1 | 0.6 |