DCP 248.07Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982171085), received between Feb 17, 2017 and Feb 17, 2017 — classified as 1 injury.

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.

• InjuryFeb 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ORIGINAL SURGERY FOR A RIGHT HUMERUS FRACTURE APPROXIMATELY TEN YEARS AGO. DURING THAT INITIAL SURGERY, A SMALL PIECE OF A 2.5 MM SYNTHES DRILL BIT BROKE AND WAS LEFT IMPLANTED INSIDE THE BONE. POST OPERATIVELY THE IMPLANTS WERE BOTHERING THE PATIENT. HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017 AND A PLATE AND 5 SCREWS WERE REMOVED, ALL WERE INTACT AND REMOVED WITHOUT ANY ISSUE. THERE WERE NO ISSUES OR DELAY DURING THE REVISION SURGERY AND THE PATIENT WAS REPORTED AS STABLE. THE PATIENT WAS NOT IMPLANTED WITH NEW HARDWARE. (B)(4) CAPTURES THE EVENT (BROKEN DRILL BIT) OCCURRED DURING INITIAL IMPLANT PROCEDURE. THIS REPORT IS FOR ONE (1) 3.5 MM DCP PLATE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Discomfort; No Code Available

  MAUDE report 6339769 ↗