LCP 245.081Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982169624), received between Mar 16, 2017 and Jan 31, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 SURGEON REMOVED A 8 HOLE LCP RECON PLATE. THE REASON FOR THE REMOVAL WAS PAIN. THERE WAS A PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES NINE(9) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 LCP RECONSTRUCTION PLATE 8 HOLES/112. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16272597 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY. DURING THE PROCEDURE, 9 SCREWS AND 1 RECON PLATE WERE REMOVED DUE TO INFECTION. THE IMPLANT DATE WAS (B)(6) 2021. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5 LCP RECONSTRUCTION PLATE 8 HOLES/112. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12626387 ↗
• InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT SCAPULA FOR FAILED FIXATION AND LOSS OF ANATOMIC REDUCTION, DUE TO PATIENT COMPLIANCE. THERE WAS NO REPORT OF MALFUNCTION WITH ANY OF THE DEVICES. A LOCKING COMPRESSION PLATE 6 HOLES, LCP RECONSTRUCTION PLATE 8 HOLES, TWO (2) 3.5MM UNKNOWN LOCKING SCREWS, NINE (9) 3.5MM UNKNOWN CORTEX SCREWS AND ONE (1) 2.7MM UNKNOWN CORTEX SCREW WERE REMOVED. BONE LOSS REQUIRED FIBULAR STRUT ALLOGRAFT PLACEMENT AND INFUSE BONE MORPHOGENETIC PROTEINS (BMP). DURING REVISION, PATIENT WAS IMPLANTED WITH NEW FIXATION. ORIGINAL IMPLANT DATE IS UNKNOWN, LESS THAN ONE YEAR PRIOR TO THE REVISION SURGERY. THE PLATES WERE INTENTIONALLY BENT OR CONTOURED DURING INITIAL IMPLANTATION. SURGICAL DELAY IS UNKNOWN. PROCEDURE WAS SUCCESSFULLY COMPLETED, AND PATIENT OUTCOME WAS AS PLANNED. THIS REPORT IS FOR ONE (1) LOCKING COMPRESSION PLATE, 8 HOLES. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7964865 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS INITIALLY TREATED ON (B)(6) 2018 WITH EXTERNAL FIXATOR APPLICATION AND FOUR COMPARTMENT FASCIOTOMY AND WOUND VAC. IRRIGATION AND DEBRIDEMENT WAS DONE ON (B)(6) 2018 AGAIN. PLANNED EXTERNAL FIXATOR REMOVAL FOR DEFINITIVE OPEN REDUCTION INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2018 AND THE PATIENT WAS IMPLANTED WITH PLATES AND SCREWS. ON (B)(6) 2018, THE IRRIGATION AND DRAINAGE OF THE WOUND WAS PERFORMED. HARDWARE WAS NOT REMOVED. SURGEON TREATING PATIENT CONSERVATIVELY AT PRESENT. SURGEON HAS STATED PATIENT IS NON-COMPLIANT DUE TO MENTAL STATUS AND HAS URINATED ON WOUNDS. THE PATIENT RETURNED TO SURGERY AGAIN ON (B)(6) 2018 FOR HARDWARE REMOVAL DUE TO INFECTION. THIS TIME HARDWARE WAS REMOVED IN ITS ENTIRETY/LATERAL AND MEDIAL SIDES. ALL HARDWARE WAS INTACT. PATIENT WAS DEBRIDED AND A NEW 4.5 LOCKING COMPRESSION PLATE (LCP) OF THE PROXIMAL TIBIA WAS INSERTED ON LATERAL SIDE. WOUND VACS WERE APPLIED TO BOTH SIDES. SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 3.5 MM LCP RECONSTRUCTION PLATE 8 HOLES/112 MM. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 7435958 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2017 DUE TO INFECTION. ALL HARDWARE WAS INTACT AND THE FRACTURE WAS HEALED. THE ORIGINAL PROCEDURE WAS AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA IN (B)(6) 2017. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE FOLLOWING SURGERY. THIS REPORT IS FOR ONE (1) 3.5 MM LCP RECONSTRUCTION PLATE 8 HOLES/112 MM. THIS IS REPORT 2 OF 6 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7161660 ↗
• InjuryMar 16, 2017Break; Break

  IT WAS REPORTED THAT TO REPAIR BOTH BONE FOREARM FRACTURE, OPEN REDUCTION INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2016 AND THE SURGERY WAS COMPLETED SATISFACTORY. UPON FOLLOW UP X-RAY, IT WAS DETERMINED THAT RECONSTRUCTION PLATE BROKE AND NON UNION WAS PRESENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE ALL THE HARDWARE AND NEW PLATE AND SCREWS WERE IMPLANTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. EXPLANTED SCREWS WERE INTACT. CONCOMITANT MEDICAL PRODUCTS: 2.7 CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), 3.5 CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 7). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 6411563 ↗

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,