GAMMA 3066-0080SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540595966), received between Oct 3, 2019 and Jan 6, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRIMARY SURGERY WAS CONDUCTED ON (B)(6) 2025. THE PATIENT HAD A FALL AND CUT OUT ON (B)(6) 2025. REVISION SURGERY WAS CONDUCTED ON (B)(6)2025."

  Patient problems: Fall; Perforation

  MAUDE report 23976920 ↗
• InjurySep 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE U-LAG SCREW IN A PATIENT WHO RECEIVED A GAMMA 3 IMPLANT DURING SURGERY ON (B)(6) 2023, BECAME CUT OUT. AFTER THE GAMMA 3 WAS EXTRACTED, MDM'S ARTIFICIAL HEAD WAS REPLACED."

  Patient problems: Perforation

  MAUDE report 23184815 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A PATIENT WHO HAD UNDERGONE INTERNAL FIXATION WITH A LONG GAMMA NAIL 3 YEARS EARLIER HAD SHOWN BONY FUSION, BUT WHEN HE/SHE FELT PAIN AND A FEMORAL NECK FRACTURE AND OSTEONECROSIS WERE FOUND. THE LAG SCREW HAD BEEN PENETRATED TO THE PELVIS, BUT BECAUSE OF HIS/HER ADVANCED AGE, THE SURGEON CHOSE TO HAVE THE REPLACEMENT WITH ONLY A BIPOLAR."

  Patient problems: Implant Pain; Limb Fracture; Necrosis; Perforation

  MAUDE report 18917218 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "CUT OUT OF LAG SCREW OCCURRED AND A REVISION SURGERY WITH THA WAS PERFORMED."

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16010431 ↗
• MalfunctionOct 3, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED: "IT WAS REPORTED THAT, DURING A SURGERY, WHEN A NURSE OPENED THE BLISTER PACKAGE, A SURGEON NOTICED A FOREIGN MATERIAL IN THE PACKAGE. A SPARE WAS USED INSTEAD." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153699 ↗