GAMMA 8160-0105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327511048), received between Jun 21, 2024 and Jul 10, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Malposition of Device; Migration

  THE FOLLOWING INFORMATION WAS REPORTED: MEDIAL MIGRATING LAG SCREW OF THE GAMMA4.

  Patient problems: Insufficient Information

  MAUDE report 25780771 ↗
• MalfunctionApr 3, 2026Migration

  AS REPORTED: "LONG GAMMA WAS IMPLANTED FOR INTERTROCHANTERIC FRACTURE OF RIGHT HIP, ABNORMAL LAG SCREW BACK OUT WAS SEEN AT 2 WEEK POST OP X RAY(TIME FRAME OF LAG SCREW BACK OUT AS WELL AS THE AMOUNT OF BACK OUT".

  Patient problems: Insufficient Information

  MAUDE report 24778626 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED: "SUBJECT: (B)(6). STRYKER PEGASUS STUDY. PAIN: PATIENT HAS SOME SORENESS LATERALLY CONSISTENT WITH IRRITATION FROM THE LAG SCREW AFTER THE FRACTURE HEAD COMPRESSED AND HEALED."

  Patient problems: Discomfort; Implant Pain; Pain

  MAUDE report 21993225 ↗
• InjuryJul 15, 2024Malposition of Device; Migration; Malposition of Device; Migration

  AS REPORTED: "A GAMMA 4 LAG SCREW BACK OUT. THIS CASE WAS REVISED WITH NEW NAIL AND SCREWS."

  Patient problems: Failure of Implant

  MAUDE report 19741444 ↗
• InjuryJun 21, 2024Positioning Failure; Migration; Positioning Failure; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED BECAUSE OF A MIGRATION OF THE GAMMA 4 LAG SCREW. PATIENT HAD PAIN 3 DAYS BEFORE THE REVISION SURGERY AND CAME IN FOR AN X-RAY WHERE THEY NOTICED THE LAG SCREW MIGRATED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19588835 ↗