GAMMA 3520-1340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252274124), received between Feb 23, 2021 and May 16, 2023 — classified as 2 injuries.

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

• InjuryMay 16, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "FRACTURE OF THE GAMMA 3 NAIL IMPLANTED ON (B)(6) 2022 LONG WITHOUT ACCIDENTAL FALL EVENT. FURTHER SURGERY ON (B)(6) 2023 WITH REMOVAL OF FRAGMENTS AND RE-OSTEOSYNTHESIS."

  Patient problems: Failure of Implant

  MAUDE report 16943309 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO AVASCULAR NECROSIS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED IMPLANTS. A GAMMA NAIL, SET SCREW, LAG SCREW, AND DISTAL SCREW WERE REVISED."

  Patient problems: Necrosis

  MAUDE report 11369166 ↗