LCP 02.113.103SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982034731), received between Aug 24, 2018 and May 29, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Migration; Migration

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID (B)(6): A 14-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FRACTURE FIXATION (ORIF OF LEFT ANKLE. MEDIAL AND LATERAL MAL). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: - INTERMITTENT PAIN AND PROMINENCE REQUIRING REMOVAL OF HARDWARE AND HOOK PLATE. IMPLANT(S) INVOLVED: 02.113.103S CORTEX SCREWS X 2. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID 133. THIS IS RELATED TO (B)(4).

  Patient problems: Pain

  MAUDE report 22107034 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, ONE OF THE DISTAL PRONGS OF THE LOCKING COMPRESSION PLATE (LCP) HOOK PLATE BROKE OFF WHEN THE SURGEON WAS TAMPING IT DOWN TO THE BONE. ANOTHER PLATE WAS USED IN ITS PLACE WITHOUT CASE DELAY. ALL FRAGMENTS ARE REMOVED WITHOUT ANY ADDITIONAL ISSUES. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 3.5MM LCP HOOK PLATE 3 HOLE STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096317 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION ON (B)(6) 2018 DUE TO FALL AND HAD A DISTAL MEDIAL TIBIAL FRACTURE WHICH IS JUST ABOVE THE LOCKING COMPRESSION PLATE THAT HAD BEEN IMPLANTED ON (B)(6) 2018 TO FIX A BROKEN ANKLE. IN ADDITION, ONE (1) LOCKING COMPRESSION PLATE (LCP) HOOK PLATE AND (2) UNKNOWN CORTEX SCREWS AND (2) UNKNOWN LOCKING SCREWS WERE REMOVED FROM A PREVIOUS ANKLE SURGERY ON THE MONTH OF (B)(6) 2018 IN ORDER TO FIT THE NEW PLATE AND SCREWS. THE ANKLE FRACTURE WAS NOTED AS HEALING WITHOUT A NON-UNION. ALL THE HARDWARE WAS INTACT. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE PATIENT WAS STABLE FOLLOWING SURGERY. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7864240 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A LOCKING COMPRESSION PLATE (LCP) HOOK PLATE AND TWO (2) 3.5MM CORTEX SCREWS DUE TO SURGICAL WOUND BREAKDOWN AND INFECTION ON (B)(6) 2018. THE PROCEDURE INCLUDED INCISION AND DRAINAGE AND TENSION BAND WITH 18 GAUGE WIRE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. THE PATIENT OUTCOME WAS REPORTED AS OKAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7814348 ↗