GAMMA 3425-0340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540375346), received between Oct 19, 2020 and Feb 17, 2022 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT FELL INTO THE GUTTER AFTER SURGERY. IT WAS NOTED THAT THE NAIL MAY HAVE BEEN FRACTURED. PSEUDOARTHROSIS WAS ALSO IDENTIFIED. THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2022.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13552761 ↗
• MalfunctionDec 22, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT AFTER INSERTING THE LAG SCREW, THE SET SCREW WAS INSTALLED AND IT WAS CONFIRMED THAT THE LAG SCREW DRIVER DID NOT ROTATE. WHEN THE END CAP WAS INSERTED, IT BECAME DIFFICULT TO INSERT. AFTER THAT IT WAS CHECKED BY X-RAY, IT WAS IN CONTACT WITH THE SET SCREW THAT SHOULD HAVE BEEN INSERTED TO THE FINAL POSITION. AFTER REINSERTING THE SET SCREW AND CONFIRMING THAT THE LAG SCREW DRIVER DID NOT ROTATE, THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059719 ↗
• InjuryOct 19, 2020Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "MY PHYSICIAN DISCOVERED WITH X RAYS THAT YOUR HARDWARE FAILED THAT WAS SURGICAL IMPLANTED IN MY RIGHT LEG ON (B)(6) 2019. ON (B)(6) 2020, A TRAUMA SURGEON REMOVED THE DEFECTIVE HARDWARE FROM MY LEG AT (B)(6). AS A RESULT, SHE HAS MISSED 8 MONTHS FROM WORK, AND SHE WILL PROBABLY MISS 2 MORE MONTHS FOR PHYSICAL THERAPY.

  Patient problems: Failure of Implant

  MAUDE report 10702571 ↗