NA 242.510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982168696), received between Dec 5, 2017 and Dec 5, 2017 — 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. How this data works · Data updated Oct 13, 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.

• InjuryDec 5, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION ON (B)(6) 2017 DUE TO BROKEN WRIST FUSION PLATE, NONUNION AND INFECTION. HARDWARE WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE OF (B)(6) 2014. THE PATIENT IS REPORTED TO HAVE PRESENTED TO THE SURGEON WITH A BROKEN PLATE, THUS LEADING TO THE HARDWARE REMOVAL BEING SCHEDULED. THE SURGEON REMOVED ONE (1) WRIST FUSION PLATE, ONE (1) DISTAL RADIAL PLATE, SEVEN (7) 2.7 MM CORTEX SCREWS AND THREE (3) 3.5 MM CORTEX SCREWS, AND REPLACED THE HARDWARE WITH A K-WIRE FIXATION INCLUDING AN UNKNOWN QUANTITY OF K-WIRES AND AN ANTIBIOTIC CEMENT FOR INFECTION. IT WAS ALSO REPORTED THAT FRAGMENTS WERE GENERATED FROM THE BROKEN WRIST FUSION PLATE AND WERE RETAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT¿S OUTCOME REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) WRIST FUSION PLATE 8 HOLES/STANDARD. (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7083522 ↗