GAMMA 3130-0170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540375117), received between Aug 1, 2016 and Sep 22, 2022 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CUT-OUT.

  Patient problems: Perforation

  MAUDE report 15466235 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CUT-OUT.

  Patient problems: Perforation

  MAUDE report 15465974 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CUT-OUT.

  Patient problems: Perforation

  MAUDE report 15465914 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CUT-OUT.

  Patient problems: Perforation

  MAUDE report 15465852 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CUT-OUT.

  Patient problems: Perforation

  MAUDE report 15465787 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CUT-OUT.

  Patient problems: Perforation

  MAUDE report 15465731 ↗
• InjuryApr 25, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN GAMMA NAIL. PATIENT HAD A NONUNION FRACTURE. PATIENT HAD PAIN AND REQUIRED A REVISION PROCEDURE. THE GAMMA NAIL WAS REMOVED."

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 14192294 ↗
• InjuryDec 26, 2019Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "AFTER TREATMENT WITH A GAMMA NAIL FOR A CERVICAL FRACTURE, THE LAG SCREW EXCESSIVELY TELESCOPED TO A CUTOUT. SURGEON THINK THERE IS A POSSIBILITY THAT THE SET SCREW DID NOT FIT INTO THE LAG SCREW." REVISION SURGERY OCCURRED AS A RESULT.

  Patient problems: Injury

  MAUDE report 9521857 ↗
• InjuryAug 1, 2016Break

  AFTER SURGERY, U-LAG SCREW CUTOUT WAS FOUND. THEREFORE A REVISION SURGERY TO BIPOLAR WAS PERFORMED ON (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 5837794 ↗