GAMMA 8166-0100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327591897), received between Jun 20, 2024 and Nov 5, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Migration; Migration

  AS REPORTED: "A GAMMA4 U-LAG SCREW PERFORATED THE PELVIS. THE PATIENT REPORTED PAIN AND THIS RESULTED IN A REVISION SURGERY." ADDITIONAL INFORMATION: AROUND (B)(6), THE PAIN IN THE LEFT HIP JOINT GRADUALLY WORSENED AND INCREASED DURING REHABILITATION. WHEN THE SURGEON RE-CHECKED THE X-RAY, IT REVEALED THAT THE LAG SCREW HAD PERFORATED THE PELVIS. IT WAS REPORTED THAT DURING PRIMARY SURGERY, THE SET SCREW WAS NOT TIGHTENED WHEN INSERTING THE U-LAG, AND THE U-BLADE WAS INSERTED WITHOUT X-RAY CONFIRMATION.

  Patient problems: Pain; Perforation

  MAUDE report 23477346 ↗
• MalfunctionSep 9, 2025Positioning Failure; Naturally Worn; Positioning Failure; Naturally Worn

  AS REPORTED: "DURING INSERTION OF THE LAG SCREW, THE LAG SCREW WAS DISPLACED ANTERIORLY INTO THE NAIL, AND THE LAG SCREW WAS REMOVED. THE PHYSICIAN THOUGHT THAT THE LAG SCREW SLEEVE MAY HAVE BEEN PUSHED UP BY THE FASCIA, SO HE ADDED A NEW SKIN INCISION AND REDID THE LAG SCREW INSERTION TECHNIQUE, STARTING FROM THE STAGE OF REINSERTING THE GUIDE PIN. THE REMOVED LAG SCREW SHOWED EVIDENCE OF ABRASION, SO WE REPLACED IT WITH A NEW ONE. THE NEW LAG SCREW WAS INSERTED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003172 ↗
• InjuryJul 29, 2025Off-Label Use; Off-Label Use

  AS REPORTED: "THE END CAP FELL OFF WHEN OPENING THE U-LAG SCREW AND BECAME UNCLEAN. THE SCREW WAS NOT REPLACED WITH ANOTHER SCREW AND THE PROCEDURE WAS COMPLETED WITHOUT INSERTING THE END CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650189 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LAG SCREW CUTOUT. REVISION SURGERY TO BIPOLAR IS REQUIRED.

  Patient problems: Insufficient Information; Perforation

  MAUDE report 21123942 ↗
• InjuryDec 17, 2024Migration; Migration

  POSTOPERATIVELY U-LAG SCREW PENETRATION HAD OCCURRED. ON (B)(6), REVISION SURGERY IS PLANNED TO BE PERFORMED.

  Patient problems: Failure of Implant; Perforation

  MAUDE report 20953217 ↗
• InjuryJul 15, 2024Positioning Problem; Positioning Problem

  AS REPORTED: "AFTER LAG SCREW INSERTED, COMPRESSION APPLIED, SET SCREW TIGHTENED AND SLIGHTLY LOOSEN, WHEN U-BLADE WAS INSERTED WITH A HAMMER GENTLY, THE FEMORAL HEAD WAS PUSHED AND THE FRACTURE SEPARATED."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741600 ↗
• MalfunctionJun 20, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT: AFTER LAG SCREW INSERTED, COMPRESSION APPLIED, SET SCREW TIGHTENED AND SLIGHTLY LOOSEN, WHEN U-BLADE WAS INSERTED, THE FEMORAL HEAD WAS PUSHED AND THE FRACTURE SEPARATED. THE SURGERY WAS FINISHED WITH PULLING THE FEMORAL HEAD BACK SOMEWHAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579140 ↗