GAMMA 8004-0010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327510942), received between Jun 11, 2024 and Jun 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 18, 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.

• MalfunctionJun 11, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "DURING THE END CAP PROCEDURE STEP, THE END CAP DID NOT FIT PROPERLY INTO THE NAIL. AT FIRST A +10MM PLUG WAS USED AND DID NOT FIT THE NAIL, AND THE +10MM PLUG WAS REPLACED WITH A +5MM PLUG BECAUSE THE THREADS OF THE +10MM PLUG MIGHT BE THE CAUSE, BUT THE +5MM PLUG DID NOT FIT THE NAIL EITHER. IN THE END, THE SURGERY WAS COMPLETED WITHOUT END CAPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513221 ↗