LCP 241.371Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982166890), received between Dec 14, 2017 and May 10, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K011335); 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT AN LCP ONE-THIRD TUBULAR PLATE AND AN UNKNOWN QUANTITY OF SCREWS FOR THE FIBULA FOR FRACTURE FIXATION ON AN UNKNOWN DATE. PROMINENT HARDWARE WAS EXPERIENCED POSTOPERATIVELY, AND HARDWARE REMOVAL WAS PERFORMED 16 WEEKS POSTOPERATIVELY. OUTCOME WAS RECOVERED/RESOLVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM . THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19288928 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BELGIUM REPORTS AN EVENT AS FOLLOWS: SUBJECT LEU-081. AE1: POSTOPERATIVE ADVERSE EVENT: "FRACTURE-RELATED INFECTION (FRI)" IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES" IS THE AE RELATED TO THE DEVICE? ¿YES". DPS IMPLANT WAS USED. THIS REPORT IS FOR AN LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18282722 ↗
• InjuryMar 27, 2023Break; Break

  IT WAS REPORTED THAT THE SURGEON WILL BE REMOVING THE 7 HOLE 3.5 1/3 TUBULAR PLATE WHICH IS BROKEN IN THE MIDDLE HOLE FROM A SCAPULA AND PERFORMING AN ORIF OF A SCAPULA. EXPLANT DATE AND PRODUCT RETURN STATUS NOT AVAILABLE THE EXACT MANUFACTURER OF PLATES ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 7 H/81. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 16622491 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT EXPERIENCED AN ALLERGIC REACTION CAUSED BY AN IMPLANT IN THE ANKLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15914051 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT REPORTED BLISTERS ON SURGICAL FOOT, WHICH HAS SPREAD TO OTHER PARTS OF HER BODY. PATIENT IS BEING TESTED FOR AN ALLERGIC REACTION TO THE IMPLANTS. NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)LCP ONE-THIRD TUBULAR PL COLLAR 7 H/81. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 15183710 ↗
• InjuryAug 1, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OP EVENT SURGEON NOTIFIED THAT HE IS GOING TO REMOVE HARDWARE FROM A DISTAL TIBIAL. THE REMOVAL OF THE HARDWARE WAS EXTRAORDINARILY DIFFICULT AND INVOLVED A LOT OF IMPROVISATION TO REMOVE THE BROKEN SCREWS. ALL OF THE HARDWARE WAS SUCCESSFULLY REMOVED EXCEPT SOME SMALL SHARDS OF TWO BROKEN SCREWS LEFT BEHIND AFTER THE OVER-MILL WAS RUN OVER THEM. THE REASON FOR THE REMOVAL WAS AN INFECTED NON UNION. THE ORIGINAL SURGERY WAS DONE ON (B)(6) 2021. IT APPEARS THAT THE SCREWS WERE BROKEN PRE-OPERATIVELY, BUT NOT NOTICED ON PRE-OP XRAYS. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 7 H/81. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

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

  MAUDE report 15141885 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021 THE PATIENT UNDERWENT REMOVAL OF (1) LOCKING COMPRESSION PLATE (LCP) PLATE, (1) UNKNOWN CANCELLOUS SCREW AND (6) UNKNOWN CORTEX SCREWS DUE TO PAIN. HARDWARE REMOVAL WAS DIFFICULT BECAUSE OF BONY OVER GROWTH, BUT THE HARDWARE CAME OUT SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12625793 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF A LOCKING COMPRESSION PLATE (LCP) ONE THIRD TUBULAR PLATE AND SCREWS DUE TO A RECURRENT INFECTION. THERE WAS NO ALLEGATION WITH THE HARDWARE THAT WAS IMPLANTED IN 2015. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. ALL OF THE HARDWARE WAS REMOVED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11046549 ↗
• InjuryMay 31, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION AS THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) BROKE AT THE NAIL/HELICAL BLADE INTERFACE. PATIENT HAD A NON UNION FRACTURE, SO THE NAIL WAS REPLACED WITH ANOTHER TFNA. IN ADDITION, THE PATIENT ALSO HAD A 7 HOLE ONE THIRD TUBULAR PLATE PLACED ON THEIR ULNA WHICH ALSO BROKE POST-OPERATIVE. PATIENT NEEDED A NEW TFNA AND RECEIVED A DISTAL RADIUS PLATE ALONG WITH A 14 HOLE 3.5 CURVED LCP PLATE ON THEIR ULNA. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE: DISTAL LOCKING SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); TFNA FENESTRATED HELICAL BLADE (PART 04.038.395, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) LCP PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8659273 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 7 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 27 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: No Code Available

  MAUDE report 8641436 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD SYMPTOMS OF SWELLING, ITCHING AND A RASH IMMEDIATELY FOLLOWING AN UNKNOWN ORTHOPEDIC PROCEDURE. THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION (LCP) ONE-THIRD TUBULAR PLATE WITH COLLAR, A CANCELLOUS BONE SCREW AND A SELF-TAPPING LOCKING SCREW DUE TO A FRACTURE. THE PATIENT IS INQUIRING IF THE IMPLANTS ARE COATED WITH "POLYETHYLENE, POLYPROPYLENE GLYCOL, OR WAX", TO WHICH THEY ARE ALLERGIC. PATIENT HAS A HISTORY OF A PRIOR UNKNOWN SURGERY INVOLVING LEVELS C4, C5, C6 AND SUFFERED AN ALLERGIC REACTION FROM AN UNKNOWN METAL OBJECT PLACED ON THE CHEST. THE PATIENT CONSULTED THE DOCTOR ON (B)(6) 2018 WITH A PERSISTENT ANKLE RASH. X-RAYS WERE TAKEN ON AN UNKNOWN DATE AND CONFIRMED THAT THE FRACTURE WAS HEALING WELL. IT WAS CONFIRMED BY ENGINEERING ON (B)(6) 2018 THAT THE DEVICES ARE 316L STAINLESS STEEL AND NOT COATED WITH POLYETHYLENE, POLYPROPYLENE GLYCOL, OR WAX. THIS REPORT IS FOR A LCP ONE-THIRD TUBULAR PLATE WITH COLLAR. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 8173393 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE A ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/49 MM, A LOCKING COMPRESSION PLATE ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81 MM, EIGHT (4.0 MM) CANCELLOUS SCREWS, AND THREE (3.5 MM) CORTEX SCREWS. THE INITIAL SURGERY DATE IS UNKNOWN BUT IT WAS FOR A FIBULA FRACTURE. THE HARDWARE REMOVAL WAS DUE TO SOFT TISSUE IRRITATION. THERE WERE NO MALFUNCTIONS WITH THE HARDWARE REMOVED, NO SURGICAL DELAYS AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH PATIENT OUTCOME NOTED AS STABLE. X-RAYS WERE TAKEN BUT UNAVAILABLE TO BE SENT. NO ADDITIONAL IMPLANTS OR MEDICAL INTERVENTIONS WERE PERFORMED ON PATIENT POST HARDWARE REMOVAL. THIS COMPLAINT INVOLVES 13 PARTS. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: Irritation; Not Applicable

  MAUDE report 7119028 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011335. One submission often covers many models, so check the product and lot details in each record.

• Z-2816-2020 · Jul 21, 2020 · Terminated
  DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, ol
• Z-1557-2013 · Feb 22, 2013 · Terminated
  Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011