MAXFRAME 03.312.830Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982261007), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.

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

• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE THREADS SNAPPED OFF THE DEVICE AND THE BALL SWIVEL FELL OUT. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MAXFRAME(TM) SHOULDER BOLT FOR 8MM RINGS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360510 ↗