GAMMA 8425-0400SRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327477955), received between Nov 20, 2025 and Apr 3, 2026 — classified as 1 injury, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
Patient problems
- Impaired Healing1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Malposition of Device
AS REPORTED: "LONG GAMMA WAS IMPLANTED FOR INTERTROCHANTERIC FRACTURE OF RIGHT HIP, ABNORMAL LAG SCREW BACK OUT WAS SEEN AT 2 WEEK POST OP X RAY(TIME FRAME OF LAG SCREW BACK OUT AS WELL AS THE AMOUNT OF BACK OUT".
Patient problems: Insufficient Information
MAUDE report 24778622 ↗InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). STRYKER PEGASUS STUDY. NON-UNION (NO BONE CONSOLIDATION WITHIN 6 MONTHS). 6 MONTH VISIT; CT (B)(6) 2025; X-RAYS (B)(6) 2025. UPDATE DURING VISIT ON SITE: THE SITE WILL BE UPDATING THE TERM FROM NONUNION TO ¿DELAYED HEALING.¿ BONE CONSOLIDATION EVENTUALLY WAS ACHIEVED AS NOTED ON THE 12 MONTH VISIT ON (B)(6) 2025.
Patient problems: Impaired Healing
MAUDE report 23603014 ↗
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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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