GAMMA 8525-2360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327475166), received between May 15, 2025 and Jul 22, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryJul 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "YESTERDAY A BROKEN LONGER GAMMA4 NAIL WAS REMOVED - IT BROKE WITHIN THE LAST 6 WEEKS AFTER IMPLANTATION. THE PATIENT CAME OUT OF REHAB AND SUDDENLY EXPERIENCED SEVERE PAIN WHILE WALKING."

  Patient problems: Pain

  MAUDE report 22570535 ↗
• InjuryMay 15, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "AT THE TIME OF THE INITIAL SURGERY, IT WAS SUSPECTED A TUMOR AT THE FRACTURE SITE AND SUBMITTED THE BONE TISSUE FOR EXAMINATION, WHICH REVEALED NECROSIS OF THE TISSUE AT THE FRACTURE SITE. AFTER SURGERY, THE PATIENT WORKED HARD ON THE REHABILITATION, BUT HE/SHE LOST STRENGTH WHILE SQUATTING AND THE NAIL FRACTURE WAS DISCOVERED. THE NAIL REMOVAL AND REPLACEMENT WITH A BIPOLAR IS SCHEDULED FOR (B)(6) 2025."

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029165 ↗