GAMMA 3230-0340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613153313007), received between Sep 11, 2015 and Sep 11, 2015 — classified as 1 malfunction.

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

• MalfunctionSep 11, 2015Positioning Problem

  IT IS REPORTED BY NURSE OF THE HOSPITAL THAT DURING A SURGERY PROCEDURE SHE OBSERVED THAT THE SURGEON HAD PROBLEMS WITH PLACING THE LAG SCREW. HE COULDN'T SCREW THE SET SCREW DEEP ENOUGH INTO THE NAIL. A NEW NAIL KIT HAS BEEN USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5072060 ↗