LCP 224.571Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982158482), received between Sep 1, 2017 and May 9, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT #29: 74-YEAR-OLD MALE WAS IMPLANTED WITH LCP METAPHYSEAL PLATES 3.5 (224.571) IN HUMERUS WITH DPS SCREWS (UNKNOWN QUANTITY) WITH NO ADJUNCTIVE FIXATION. POST-OPERATIVE COMPLICATION: NON-UNION EXPERIENCED 24 WEEKS POST-OP RELATED TO SYNTHES PROCEDURE. TREATMENT: SURGICAL TREATMENT FOR REPAIR NON-UNION REMOVAL OF PLATE AND SCREWS AND RE-FIXATION WITH HUMERAL NAIL PERFORMED 24 WEEKS POST-OP. OUTCOME: RECOVERED/RESOLVED. THIS REPORT IS FOR A 4.5MM NARROW LCP® PLATE 7 HOLES/134MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19278612 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A NONUNION OF MIDSHAFT HUMERUS AND DELAYED HEALING. THE SURGEON REMOVED ONE (1) 7 HOLES NARROW LOCKING COMPRESSION PLATE (LCP) AND SEVEN (7) 4.5MM CORTEX SCREWS. THE PATIENT WAS REVISED WITH ONE (1) 9 HOLES NARROW LOCKING COMPRESSION PLATE (LCP) WITH SCREWS. THE ORIGINAL SURGERY WAS DONE FEW MONTHS AGO. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE OUTCOME WAS SUCCESSFUL. THIS REPORT IS FOR ONE (1) 4.5MM NARROW LCP PLATE 7 HOLES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7929625 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION OF A PLATE AND SIX SCREWS ON (B)(6) 2017 DUE TO NONUNION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON (B)(6) 2017 FOR A RIGHT MIDSHAFT TIBIAL FRACTURE. AT THE TIME OF THE ORIGINAL SURGERY, THE PATIENT HAD REFUSED TREATMENT WITH A NAIL. A NONUNION WAS DISCOVERED ON AN UNKNOWN DATE POSTOPERATIVELY. THE PLATE AND SCREWS WERE REMOVED INTACT AND PATIENT WAS REVISED TO A NAIL AND LOCKING SCREWS WITH BONE GRAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) 4.5 MM NARROW LCP PLATE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6839493 ↗