GAMMA 3230-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153313021), received between Jan 14, 2019 and Feb 25, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2019Fracture

  THE PATIENT FELL ON (B)(6) 2017 AND CONTRACTED A PROXIMAL FEMUR FRACTURE. ON (B)(6) 2017, THE OPERATIVE RESTORATION WAS PERFORMED USING A PROXIMAL FEMORAL NAIL. INITIAL REGULAR COURSE. AT THE CLINICAL RADIOLOGICAL CHECK ON (B)(6) 2018, THE IMPLANT WAS INTACT WITH A PARTIALLY CONSOLIDATED FRACTURE. SINCE (B)(6) 2018 INCREASED PAIN. THE EXTERNAL RADIOGRAPH REVEALED A NAIL FRACTURE. AT THE PERFORMANCE IN AUGUST, THE PATIENT WAS PAIN-COMPENSATED. BECAUSE OF THE FURTHER COMPENSATED SITUATION AND THE RESTRAINED ATTITUDE OF THE PATIENT TOWARDS SURGERY, NO REVISION HAS BEEN PERFORMED SO FAR AND THE IMPLANT IS STILL IN SITU.

  Patient problems: Pain

  MAUDE report 8367221 ↗
• InjuryJan 14, 2019Fracture; Fracture

  IMPLANTING A LONG STRAIGHT GAMMA TITANIUM ROD INTO THE PATIENT ON (B)(6) 2018, BUT ON (B)(6) 2018 THE PATIENT UNDERWENT A NEW SURGERY BECAUSE THE ROD HAD BROKEN. NECESSARY NEW MEDICAL PROCEDURE. REVISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8246193 ↗