GAMMA 8425-0380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327479133), received between Jun 21, 2024 and Jan 21, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Fracture

  IT WAS REPORTED THAT THE GAMMA4 LONG NAIL HAD FRACTURED NEAR THE LAG SCREW HOLE. CONSEQUENTLY, A REVISION SURGERY IS SCHEDULED TO REMOVE THE GAMMA4 LONG, REINSERT THE NAIL, AND ADD A PLATE.

  Patient problems: Insufficient Information

  MAUDE report 24129447 ↗
• InjuryJun 21, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED BECAUSE OF A MIGRATION OF THE GAMMA 4 LAG SCREW. PATIENT HAD PAIN 3 DAYS BEFORE THE REVISION SURGERY AND CAME IN FOR AN X-RAY WHERE THEY NOTICED THE LAG SCREW MIGRATED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19589951 ↗