LCP 247.374Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982170880), received between Sep 11, 2018 and Jun 11, 2024 — classified as 4 injuries, 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K063049); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 2.7MM LCP(TM) PLATE 10 HOLES/94MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 19511055 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Malunion of Bone

  MAUDE report 18004621 ↗
• InjuryNov 2, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON INFORMED THAT PRIOR TO THE CASE A REVISION WAS NEEDED DUE TO A PLATE BREAKAGE. PATIENT CONSEQUENCE WAS REPORTED. CONCOMITANT DEVICE REPORTED - UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM LCP(TM) PLATE 10 HOLES/94MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15716998 ↗
• MalfunctionJun 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.7MM LOCKING COMPRESSION PLATE (LCP) 10 HOLES WAS RECEIVED BENT; THE SHIPPING BOX WAS DAMAGED. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.7MM LCP PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10196631 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY OF THE LOCKING COMPRESSION PLATE (LCP) PLATE 10 HOLES, ONE (1) LOCKING SCREW AND FIVE (5) CORTEX SCREWS ON (B)(6) 2018, DUE TO THE PLATE BEING PROMINENT ON THE BONE AND UNCOMFORTABLE TO THE PATIENT. NO NEW IMPLANTS WERE NEEDED DUE TO THE CLAVICLE FRACTURE BEING HEALED. THE REMOVED IMPLANTS WERE REPORTED TO BE IN GOOD CONDITION. ORIGINALLY PATIENT UNDERWENT A SURGERY ON (B)(6) 2016, DUE TO A CLAVICLE FRACTURE, AND WAS REVISED ON (B)(6) 2017 DUE TO AN OVERACTIVE TRAPEZIUS TENDON THAT RESULTED IN A BENT PLATE (THIS EVENT WAS CAPTURED ON (B)(4) COMPLAINT (B)(4)). REVISION SURGERY RECENTLY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 5.0 LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS 32MM (PART #: 212.210, LOT #: UNKNOWN, QUANTITY: 1), 2.7MM CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 12MM (PART #: 202.872, LOT #: UNKNOWN, QUANTITY: 2), 2.7MM CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM (PART #: 202.876, LOT #: UNKNOWN, QUANTITY: 1), 2.7MM CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM (PART #: 202.876, LOT #: UNKNOWN,

  Patient problems: Discomfort; No Code Available

  MAUDE report 7866893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen