GAMMA 8425-2400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327476040), received between Jun 12, 2024 and Jun 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 18, 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.

• MalfunctionJun 12, 2024Malposition of Device; Malposition of Device

  AS REPORTED: "ORIF WAS PERFORMED FOR A MALE PATIENT WITH RIGHT FEMORAL TROCHANTERIC FRACTURE. AFTER TIGHTENING THE SET SCREW, THE SURGEON FOUND THAT THE BONE HEAD COULD BE ROTATED WHILE THE NAIL WAS IMPLANTED. THUS, THE SURGEON ATTEMPTED TO LOOSEN THE SET SCREW TO ADJUST THE ROTATIONAL ALIGNMENT BY THE LAG SCREW. HOWEVER, THE SET SCREW WAS NOT LOOSENED EVEN THOUGH THE SURGEON TRIED TO TURN IT BOTH CLOCKWISE AND COUNTERCLOCKWISE. EVENTUALLY, THE LAG SCREW BEGAN TO TURN SLIGHTLY, SO THE SURGEON COMPLETED THE SURGERY BY ADJUSTING THE LAG SCREW AND RETIGHTENED THE SET SCREW WHILE THE SET SCREW DID NOT TURN SMOOTHLY EVEN AFTER ADJUSTING THE LAG SCREW."

  Patient problems: Insufficient Information

  MAUDE report 19522343 ↗