GAMMA 8425-1380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327479553), received between Jul 26, 2024 and Sep 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Break; Fracture; Break; Fracture

  AS REPORTED BY THE REP: "DATE OF ORIGINAL FIX (B)(6) 2024. DATE OF IMPLANT FAILURE (B)(6) 2025. PLANNED FOR REVISION. IMPLANTS WILL BE RETURNED. (B)(6) FOR PRIMARY AND REVISION SURGERY." FURTHER INFORMATION FROM REP: "NO EVENTS AS SUCH, PRESENTED WITH HIP PAIN. NO FALL AS FAR AS WE KNOW. "

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 22950337 ↗
• InjuryJan 21, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "BROKEN NAIL DURING WALKING. PATIENT HAD A GOOD REVALIDATION GOING ON. NOW SUDDENLY DURING DAY MALALIGNMENT PICTURE: BROKEN NAIL. BROKE 2 MONTHS LATER."

  Patient problems: Insufficient Information; Malunion of Bone

  MAUDE report 21196748 ↗
• InjuryJul 26, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO MEDIAL MIGRATION OF THE LAG SCREW. THE LAG SCREW WAS NOT ENGAGED. IT WAS NOT FULLY SET OR CENTERED IN THE GROOVE. THE SURGEON REVISED WITH A SHORTER RC. THERE WAS MINIMAL PURCHASE IN THE HEAD.

  Patient problems: Failure of Implant

  MAUDE report 19844913 ↗