PT  - JOURNAL ARTICLE
AU  - Kazarian, Gregory S.
AU  - Jordan, Yusef J.
AU  - Johnson, Mitchell
AU  - Bhargava, Satyaj
AU  - Cecere, Robert
AU  - Hirase, Takashi
AU  - Qureshi, Sheeraz
AU  - Dowdell, James
AU  - Sheha, Evan
AU  - Lovecchio, Francis
AU  - Iyer, Sravisht
TI  - Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database
AID  - 10.14444/8652
DP  - 2024 Sep 26
TA  - International Journal of Spine Surgery
PG  - 8652
4099  - https://www.ijssurgery.com/content/early/2024/09/25/8652.short
4100  - https://www.ijssurgery.com/content/early/2024/09/25/8652.full
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.