GAMMA 8130-0170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327479744), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Fracture; Fracture

  AS REPORTED: "A PATIENT WHO UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) FOR A TROCHANTERIC FRACTURE OF THE FEMUR ON (B)(6) 2025. A LAG SCREW FRACTURED AT THE SCREW HOLE SITE, NECESSITATING REVISION SURGERY ON (B)(6) 2025. THE SURGEON DETERMINED THE CAUSE TO BE A CRACK IN THE LATERAL WALL OF THE PROXIMAL FEMUR AND INADEQUATE REDUCTION. THE NAIL FRACTURE WAS DETECTED DURING A POSTOPERATIVE FOLLOW-UP OUTPATIENT VISIT. THE PATIENT REPORTED NO PAIN OR OTHER SYMPTOMS. ALTHOUGH BONE UNION HAD NOT OCCURRED, NO FURTHER FRACTURES RELATED TO THE NAIL FRACTURE WERE IDENTIFIED. UPDATE NOVEMBER 17, 2025. "ONLY THE NAIL BROKE. IT BROKE AT THE SCREW HOLE WHERE THE LAG SCREW IS INSERTED."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23790273 ↗