LCP 224.581Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982158505), received between Feb 21, 2018 and Feb 21, 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.

• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD ORIGINAL SURGERY PERFORMED ON (B)(6) 2014. PATIENT WAS REVISED ON (B)(6) 2015 DUE TO NON-UNION. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2018 DUE TO NONUNION OF HUMERUS AND ONE BROKEN 4.0 MM LOCKING SCREW. DURING REVISION SURGERY THE HEAD OF THE BROKEN SCREW WAS REMOVED AND THE SHAFT OF THE SCREW WAS LEFT INSIDE THE PATIENT. ALSO, ONE (1) 4.5 MM NARROW LCP PLATE 8 HOLES/152 MM, THREE (3) 4.5 MM CORTEX SCREWS, THREE (3) 3.5 MM CORTEX SCREWS, ONE (1) 3.5 MM LCP PLATE 6 HOLES 85 MM, TWO (2) 3.5 MM LOCKING SCREWS AND TWO (2) 4.0 MM LOCKING SCREWS WERE REMOVED INTACT. THE FRACTURE ENDS WERE SHORTENED AND THE PATIENT WAS REPLATED WITH A 7 HOLE 4.5 MM BROAD PLATE (VIVIGEN BONE GRAFT). THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND WITHOUT ANY OTHER MEDICAL INTERVENTION REQUIRED. PATIENT WAS REPORTED TO BE OKAY AFTER THE SURGERY. LATER, IT WAS INFORMED BY THE HOSPITAL THAT THE INTRA-OP CULTURES CAME BACK POSITIVE FROM THE DAY OF SURGERY. THE DOCTOR HAS DECIDED TO USE ANTIBIOTICS FOR TREATMENT OF THE INFECTION. THIS REPORT ADDRESSES SECOND REVISION SURGERY DUE TO BROKEN SCREW AND INFECTION. THE FIRST REVISION SURGERY DUE TO NON-UNION

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

  MAUDE report 7287475 ↗