NA 245.18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982169761), received between Dec 12, 2017 and Dec 12, 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. 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.

• InjuryDec 12, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT WAS TREATED IN (B)(6) ON AN UNKNOWN DATE FOR A RIGHT RADIUS FRACTURE. ON A SUBSEQUENT UNKNOWN DATE, THE PATIENT PRESENTED TO THE SURGEON COMPLAINING OF WRIST PAIN. X-RAYS TAKEN ON AN UNKNOWN DATE IDENTIFIED A BROKEN PLATE. RIGHT RADIUS HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. A BROKEN 8-HOLE LC-DCP (LIMITED CONTACT DYNAMIC COMPRESSION PLATE) RECONSTRUCTION PLATE AND SIX INTACT 3.5MM CORTEX SCREWS (NON-SELF-DRILLING) WERE REMOVED. PATIENT WAS REVISED TO A METAPHYSEAL PLATE. THERE WAS NO SURGICAL DELAY, NO RETAINED FRAGMENTS, AND THE PROCEDURE WAS COMPLETED. THE PATIENT OUTCOME WAS STABLE. THERE IS ONE DEVICE INVOLVED IN THIS COMPLAINT. REPORTED CONCOMITANT DEVICES: 3.5MM CORTEX SCREWS, NON-SELF-DRILLING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 6). THIS REPORT IS FOR ONE (1) 3.5MM RECONSTRUCTION PLATE 8 HOLES/94MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7110596 ↗