LCP 245.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982169655), received between Nov 9, 2017 and Mar 13, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000684); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2025 THERE WAS HARDWARE REMOVAL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21592872 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON WILL BE REVISING AN ULNA FRACTURE AND POSSIBLY A RADIUS FRACTURE ON (B)(6) 2023 BECAUSE OF A MAL-REDUCTION. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5 LCP RECONSTRUCTION PL 10 HOLES/140. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: Malunion of Bone

  MAUDE report 16452337 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL OF A RETROGRADE /ANTEGRADE FEMORAL NAIL (RAFN), ONE (1) LOCKING COMPRESSION (LCP) RECONSTRUCTION PLATE, AND NINE (9) UNKNOWN SCREWS DUE TO NONUNION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM LCP RECONSTRUCTION PLATE 10 HOLES/140M. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13771248 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 05, 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE FROM PROXIMAL TIBIA DUE TO INFECTION. ORIGINALLY, THE PATIENT HAD IMPLANTATION IN 2013. ALL HARDWARE REMOVED INTACT SIMULTANEOUSLY WITH INCISION AND DRAINAGE (I&D). IT WAS REPORTED THAT FRACTURED WAS HEALED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORTED. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9130013 ↗
• InjuryJul 16, 2019Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. FURTHER IT WAS REPORTED THAT DEBRIDEMENT WAS PERFORMED FOR PROPHYLACTIC MEASURES AND TO IMPLANT A NEW PLATE. CULTURES TAKEN AND SENT BUT REPORT STATES NO GROWTH. HARDWARE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES TOTAL 12 DEVICES. THIS COMPLAINT (B)(4) REPORTS 10 DEVICES, REMAINING 2 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). CONCOMITANT DEVICE REPORTED: CORTEX SCREWS (PART # 204.816 LOT # 1314, QUANTITY 4), CORTEX SCREW (PART # 204.812 LOT # 1314, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM LCP RECONSTRUCTION PLATE 10 HOLES/140MM. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8794362 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE, FOUR (4) CORTEX SCREWS, ONE (1) CANCELLOUS SCREW AND (1) CANNULATED SCREW FROM THE ANKLE DUE TO PAIN. ALL HARDWARE CAME OUT SUCCESSFULLY AND FRACTURES WERE HEALED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING COMPRESSION PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8611556 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THREE LOCKING SCREWS WERE BROKEN, BUT IT WAS DIFFICULT TO DETERMINE IF THE SCREWS BROKE DURING REMOVAL OR IF THEY WERE ALREADY BROKEN. A PART OF THE BROKEN SCREW REMAINED IN THE SHAFT OF THE BONE. THIS REPORT IS FOR THE POST-OPERATIVE NON-UNION. THE BROKEN LOCKING SCREWS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8333811 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A TIBIAL FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION RECONSTRUCTION PLATE 10 HOLES/140MM, THREE (3) 3.5MM LOCKING SCREWS WITH RECESS 38MM AND ONE (1)3.5MM LOCKING SCREW WITH RECESS 44MM. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT WAS PRESENTED WITH EXPOSURE OF HARDWARE AT THE TIBIA BONE. THE SOFT TISSUE HAD ERODED AROUND THE CONSTRUCT IMPLANT SITE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS. THE TIBIAL BONE FRACTURED HAS HEALED, SO NO NEW BONE FIXATION WAS NEEDED. NO INFECTION WAS REPORTED AND IT WAS OBSERVED THAT THE IMPLANTS WERE IN GOOD CONDITION WHEN REMOVED. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5MM LCP RECONSTRUCTION PLATE 10 HOLES/140MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7105101 ↗
• InjuryNov 9, 2017Break; Break

  IT WAS REPORTED THAT A PROXIMAL ULNA REVISION WAS PERFORMED DUE TO A BROKEN PLATE AND NONUNION ON (B)(6) 2017. THE ORIGINAL RIGHT SIDED ULNA REPAIR WAS PERFORMED ON (B)(6) 2017. ON AN UNKNOWN DATE POST-OPERATIVELY, IT WAS DISCOVERED THAT THE PLATE HAD BROKEN AND THE FRACTURE WAS IN NONUNION. REMOVED HARDWARE INCLUDED: ONE TEN-HOLE LOCKING COMPRESSION (LCP) RECON PLATE (BROKEN IN THE MIDDLE OVER A SCREW HOLE), THREE CORTEX SCREWS (INTACT) AND FIVE LOCKING SCREWS (INTACT). DURING THE REVISION PROCEDURE, THE FRACTURE WAS OPENED, IRRIGATED, AND RE-PLATED. CULTURES WERE TAKEN TO RULE OUT INFECTION. NO INFECTION WAS FOUND. THE PATIENT WAS REVISED TO AN EIGHT-HOLE OLECRANON PLATE AND SCREWS. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR SURGICAL DELAY REPORTED. THE REVISION WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES 1 DEVICE CONCOMITANT DEVICES: UNKNOWN CORTEX SCREW (PARTIAL PART# , LOT UNKNOWN, QTY 3). UNKNOWN LOCKING SCREW (PARTIAL PART#, LOT UNKNOWN, QTY 5). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7015982 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,