GAMMA 8520-0400SRecalls & reported problems
Stryker GmbH · Long Nail, LEFT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327475975), received between Oct 28, 2024 and Oct 28, 2024 — classified as 1 injury.
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
Patient problems
- Swelling/ Edema1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6) POST MARKET CLINICAL EVALUATION OF GAMMA 4: PROSPECTIVE, MULTICENTER, FOLLOW-UP STUDY (PEGASUS). DEEP VEIN THROMBOSIS. PATIENT NOTICED ACUTE WORSENING OF LEFT LEG SWELLING ON (B)(6) 2024. HE REPORTED TO SURGEON WHO RECOMMENDED DVT STUDY. US AT ED ON 04 JUN SHOWED DVT OF LEFT PERONEAL VEIN. PCP PRESCRIBED ELOQUIS FOR AT LEAST 3-MONTH COURSE. STILL TAKING AS OF (B)(6) 2024.".
Patient problems: Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 20543744 ↗
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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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