GAMMA 8425-1360SRecalls & reported problems
Stryker GmbH · Long Nail, RIGHT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327476224), received between Jan 2, 2024 and Mar 26, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Malposition of Device” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device1
- Migration1
Patient problems
- Perforation2
- Cyst(s)1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2025Migration; Migration
IT WAS REPORTED BY THE CUSTOMER THAT A GAMMA4 LAG SCREW BACKED OUT DURING PROCEDURE. POSTOPERATIVELY THE LAG SCREW WAS SEEN BACKED OUT OF THE NAIL. REVISION OF GAMMA NAIL WAS NECESSARY DUE TO FAILED FIXATION.
Patient problems: Insufficient Information; Perforation
MAUDE report 21701328 ↗InjuryJan 2, 2024Malposition of Device; Malposition of Device
AS REPORTED: "GAMMA4 NAIL TO FIX AN INTERTROCH FX. 4-6 WEEK POST OP XRAYS LOOKED NORMAL, AS EXPECTED. PT THEN PRESENTED TO ED 12/9, -XRAYS SHOWED LAG SCREW COMPLETELY DISENGAGED AND MEDIALIZED. PATIENT NEEDED REVISION SURGERY.
Patient problems: Cyst(s); Perforation
MAUDE report 18426894 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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