RT Journal Article
SR Electronic
T1 Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database
JF International Journal of Spine Surgery
JO Int J Spine Surg
FD International Society for the Advancement of Spine Surgery
SP 8652
DO 10.14444/8652
A1 Kazarian, Gregory S.
A1 Jordan, Yusef J.
A1 Johnson, Mitchell
A1 Bhargava, Satyaj
A1 Cecere, Robert
A1 Hirase, Takashi
A1 Qureshi, Sheeraz
A1 Dowdell, James
A1 Sheha, Evan
A1 Lovecchio, Francis
A1 Iyer, Sravisht
YR 2024
UL https://www.ijssurgery.com/content/early/2024/09/25/8652.abstract
AB Background Interspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs.Study Design This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database.Methods The database was queried from its inception to November 2022 for reports associated with “Prosthesis, Spinous Process Spacer/Plate.” Entries were categorized by event type, patient impact, and interventions.Results A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, n = 374) and fractures (2.2%, n = 21). The most common postoperative events were persistent pain (26.6%, n = 251), implant migration (19.1%, n = 180), and fracture (6.8%, n = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, n = 460). The need for revision surgery was common in patients who experienced fracture (47.1%), implant migration (84.5%), infection (76.7%), and neurological complications (76.9%). Implant migration, fracture, and implant malfunction, 3 complications that are unique to decompression with an IPD as compared with traditional laminectomy, accounted for 45.9% of revisions (211/460), and revision was required in 33.0% of cases where 1 of these complications was reported (211/640). Implant malfunction made up 21.2% of Coflex complications, 47.3% of Superion complications, and 5.2% of X-Stop complications.Conclusions The most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants.Clinical Relevance Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery.Level of Evidence 4.