MAXFRAME 03.312.150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982260819), received between Jan 18, 2019 and Jan 18, 2019 — classified as 1 injury.

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.

• InjuryJan 18, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MAXFRAME FULL RING BROKE ON THE PATIENTS FRAME WHICH WAS BEING USED TO TREAT A DISTAL TIBIA FRACTURE. THE ORIGINAL IMPLANT PROCEDURE WAS ON (B)(6) 2018. THE BROKEN RING WAS REPLACED ON (B)(6) 2019, WITH A 150MM 5/8 RING AND BRIDGE PLATE. THE PATIENT ALSO BROKE TWO (2) SMOOTH WIRES AND ONE (1) OLIVE WIRES. THE WIRES WERE ALSO REPLACED WITH NEW ONES. IT IS UNKNOWN IT THERE WAS SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) MAXFRAME(TM) FULL RING 150MM ALUMINUM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8261151 ↗