LCP 02.108.331Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982029874), received between Jun 7, 2018 and Jun 7, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Separation Failure” (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.

• InjuryJun 7, 2018Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF A PEDIATRIC OSTEOTOMY PLATE ON (B)(6) 2018. THE PLATE REMOVAL WAS A PATIENT¿S CHOICE AFTER A SUCCESSFUL HEALING. DURING THE PROCEDURE, THERE WAS A LOCKING SCREW FUSED INTO THE PLATE AND WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREW, THE HEAD STRIPPED. THE CONICAL EXTRACTOR WAS THEN USED BUT IT BROKE INSIDE THE SCREW. THE SURGEON WANTED TO SAW THE PLATE TO SEPARATE IT FROM THE SCREW; HOWEVER, THERE WAS NO SAW AVAILABLE IN THE HOSPITAL. THE PLATE WAS NOT SUCCESSFULLY REMOVED. THERE WAS A SURGICAL DELAY FOR APPROXIMATELY FORTY (40) MINUTES. THE SURGEON CLOSED THE INCISION. THE PLATE REMOVAL WAS DONE ON UNKNOWN DATE USING A SAW IN ANOTHER FACILITY. IN ADDITION, THE PATIENT STATUS WAS REPORTED STABLE. THIS REPORT ADDRESSES ISSUE OF A LOCKING SCREW FUSED INTO THE PLATE, THEREFORE THE PLATE COULD NOT BE REMOVED. THE INTRAOPERATIVE ISSUE OF CONICAL EXTRACTOR BREAKAGE IS CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE 3.5MM/130°/5 HOLES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7579272 ↗