GAMMA 3520-1360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252274148), received between Feb 25, 2020 and Feb 25, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT : "THE FRACTURE OF THE ABOVE MEDICAL DEVICE WAS NOTED BY RADIOGRAPHIC EXAMINATION AT 3 MONTHS POST-OPERATIVE. THE PATIENT WAS TAKEN BACK FOR NAIL REPLACEMENT. THE CAUSE OF THE FRACTURE REMAINS UNEXPLAINED (NO FALL). A STATEMENT WAS SENT TO THE (B)(6).

  Patient problems: Failure of Implant; Injury

  MAUDE report 9751752 ↗