LCP 249.683Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982171283), received between Oct 31, 2018 and Feb 26, 2026 — classified as 3 injuries, 1 malfunction.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Break

  PROCEDURE: STROKE PROCEDURE. DESCRIPTION OF ISSUE: CEREBASE BROKE WHILE UNPACKING. WHEN DID THE EVENT OCCUR (PRE-OP/INTRA-OP/POST-OP)? PRE-OP. WAS THERE ANY PATIENT CONSEQUENCE? NO. WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? NEW PRODUCT. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE (MINUTES)? NOT CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454718 ↗
• InjuryOct 2, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, THE 2.7MM LOCKING COMPRESSION PLATE (LCP) 7 HOLES/67MM PLATE THAT WAS USED TO REPAIR A RADIUS FRACTURE WAS BENT. THE PATIENT WAS LIFTING WEIGHTS AND AS HE WENT TO LOWER THE 95-POUND BARBELL THE PLATE BENT AND REFRACTURED HIS RADIUS. THE PLATE WAS REMOVED, AND IT REPLACED BY A LARGER ONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFUL AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM LCP(TM) PLATE 7 HOLES/67MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9145615 ↗
• InjuryMay 29, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE ON AN UNKNOWN DATE DUE TO BROKEN 2.7 MM LOCKING COMPRESSION PLATE (LCP). THE BROKEN LOCKING COMPRESSION PLATE AND SEVEN (7) INTACT SCREWS WERE REMOVED DURING HARDWARE REMOVAL SURGERY AND PATIENT WAS REVISED WITH 2.7/3.5 VARIABLE ANGLE (VA) OLECRANON PLATE AND 2.7 LCP PLATE. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 7). THIS REPORT IS FOR ONE (1) 2.7 MM LCP PLATE 7 HOLES/67 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8649671 ↗
• InjuryOct 31, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE ANTEROLATERAL DISTAL TIBIA PLATE, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE DISTAL TIBIA T-PLATE, AND ONE (1) LOCKING COMPRESSION PLATE BROKE DUE TO PATIENT FALLING. PATIENT HAD NONUNION. AS A RESULT, ON AN UNKNOWN DATE, THE HARDWARE OF THE ANKLE WERE REMOVED AND REPLACED WITH A SYNTHES MAX FRAME. IT WAS UNKNOWN IT THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) TIBIA PLATE. THIS IS REPORT 3 OF 3 FOR (B)(4).

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

  MAUDE report 8025659 ↗

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