LC-DCP 223.60Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982157980), received between Jan 23, 2018 and Jan 23, 2018 — 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.

• InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT ELBOW HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018 DUE TO PATIENT COMPLAINTS OF PAIN. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN 2006, AND WAS REVISED IN 2014. REMOVED HARDWARE INCLUDED TWO INTACT PLATES AND A TOTAL OF TWELVE INTACT CORTICAL SCREWS (A COMBINATION OF 3.5 MM AND 2.7 MM). ONE 3.5 MM CORTICAL SCREW HEAD BROKE OFF DURING THE REMOVAL. THE BROKEN SCREW HEAD AND THE EMBEDDED SHAFT WAS RETRIEVED. THERE WAS A SURGICAL DELAY OF FIVE MINUTES TO RETRIEVE THE SCREW SHAFT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. NO SIGNS OF INFECTION. THE AREA WAS FULLY HEALED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THE COMPLAINT OF SCREW BROKEN INTRA-OP IS CAPTURED IN (B)(4). THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7212200 ↗