LCP 441.381Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982221841), received between Mar 13, 2020 and Apr 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN HARDWARE REMOVAL PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) TI LCP ONE-THIRD TUB PL COLLAR 8 H/93 THIS REPORT IS 1 OF 11: (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716694 ↗
• InjuryMar 25, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN IN-PATIENT PROCEDURE, THE TITANIUM LOCKING COMPRESSION PLATE ONE THIRD TUBULAR PLATE WITH COLLAR 8 HOLES WAS BROKEN. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN. LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TI LCP® ONE-THIRD TUBULAR PLATE W/COLLAR 8 HOLES/ 93MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9877997 ↗
• InjuryMar 13, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION SURGERY OF THE FIBULA AND TIBIA FRACTURE DUE TO THE BROKEN UNKNOWN TUBULAR PLATE. A COMPETITOR PLATE WAS PUT IN. EASILY WITHOUT ADDITIONAL INTERVENTION. IN ADDITION, THE PLATE DID NOT BREAK DURING SURGERY. IT BROKE PRIOR TO THE REVISION, AND BETWEEN THE DATES OF (B)(6) 2019 AND (B)(6) 2020. OTHER MEDICAL INTERVENTION, AUTOGENOUS BONE GRAFT HARVEST FROM ILIAC CREST. NO DELAYS, NO FRAGMENTS GENERATED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT PRODUCTS: 3.5MM TI CORTEX SCREW SELF-TAPPING 10MM (PART # : 404.810 LOT # UNKNOWN, QUANTITY # 1), 3.5MM TI CORTEX SCREW SELF-TAPPING 12MM (PART # : 404.812 LOT # UNKNOWN, QUANTITY # 5), 3.5MM TI CORTEX SCREW SELF-TAPPING 14MM (PART # : 404.814 LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9831948 ↗

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