MAXFRAME 03.312.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982260833), received between Jun 21, 2019 and Jun 21, 2019 — 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.

• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, A MAXFRAME FULL RING REMOVAL WAS PERFORMED WHEREIN ALL THE FRAMES WERE REMOVED FROM THE PATIENT. DURING THE PROCEDURE, IT WAS OBSERVED THAT SOME OF THE RINGS HAD SOME CORROSION. THE SURGEON TESTED THE PATIENT'S SKIN FOR INFECTION, HENCE, THE OUTCOME WAS OKAY AND FINE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN), WIRE (PART/LOT UNKNOWN, QUANTITY UNKNOWN). DURING THE INVESTIGATION BY THE MANUFACTURER, IT WAS NOTED THE DEVICE WAS ALSO BROKEN. THIS REPORT IS FOR A MAXFRAME FULL RING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723936 ↗