GAMMA 3525-0280SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540375704), received between Sep 13, 2018 and Jun 4, 2021 — classified as 2 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 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.

• InjuryJun 4, 2021Break; Break

  IT WAS REPORTED THAT AFTER SURGERY, THE NAIL BROKE; REVISION SURGERY WAS PERFORMED AS A RESULT. IT WAS ALSO REPORTED THAT THE REVISION SURGERY TOOK A LOT OF TIME, BUT NO SPECIFIC AMOUNT WAS GIVEN.

  Patient problems: Failure of Implant

  MAUDE report 11942710 ↗
• InjurySep 13, 2018Break

  THE PRIMARY SURGERY WITH GAMMA NAIL WAS PERFORMED ON (B)(6) 2017. ABOUT 10 MONTHS LATER, THE NAIL BREAKAGE DUE TO FALSE JOINT WAS OBSERVED THEN REVISION SURGERY WAS PERFORMED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7875038 ↗