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VA-LCP 02.127.230Recalls & reported problems

Synthes GmbH · 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/RIGHT · Class 2 · Implant

All models of VA-LCP (256)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982043542), received between Jun 25, 2018 and Jul 9, 2025 — classified as 2 injuries, 1 malfunction.

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

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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Break1
  • Corroded1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • Nonunion/Delayed-union Bone Fracture1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENTS CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22459614 ↗
  • InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A SURGEON WILL BE REVISING A PROXIMAL TIBIA BECAUSE OF A NONUNION ON (B)(6) 2023. THE ORIGINAL SURGERY WAS DONE ON (B)(6) 2012. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE HARDWARE WAS SUCCESSFULLY REMOVED AND REVISED WITH ANOTHER PLATE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5 VA PROX TIB PL SMALL BEND/8H/147/RT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 16875541 ↗
  • InjuryJun 25, 2018Adverse 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 REMOVAL OF ELEVEN (11) LOCKING SCREWS, FOUR (4) CORTEX SCREWS, ONE (1) CANNULATED SCREW, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION (LCP) PROXIMAL TIBIA PLATE, AND ONE (1) LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE DUE TO INFECTION. THERE WAS NO DELAY IN SURGERY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) 3.5 MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147 MM/RIGHT. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 7634247 ↗

Other Screw, fixation, bone devices

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Sources and updates

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