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VA-LCP 02.127.260SRecalls & reported problems

Synthes GmbH · 3.5MM VA-LCP PROX TIBIA PLATE SMALL BND/14H/237MM/RT-STER · Class 2 · Implant

All models of VA-LCP (256)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982043672), received between May 2, 2019 and Apr 21, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Maintain” (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.

Most reported problems

Device problems

  • Device Difficult to Maintain1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 21, 2023Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED, THAT ON AN UNKNOWN DATE, THE PLATE HOLES WERE STRIPPED WHILE RESETTING IN SPD. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BND/10H/177MM/LT-STER. THIS IS REPORT 2 OF 2 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16788428 ↗
  • InjuryMay 2, 2019Device Difficult to Maintain; Device Difficult to Maintain

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PERCUTANEOUS DRILL BIT BROKE DURING DRILLING AND A BACK UP DEVICES WAS AVAILABLE. IT WAS NOTED THAT THE VARIABLE ANGLE LOCKING SCREW DID NOT LOCK IN THE HOLE WHERE THE DRILL BIT WAS LEFT. THERE WERE FRAGMENTS GENERATED. THE SURGEON LEFT THE HOLE EMPTY AND MOVED TO ANOTHER HOLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BND/14H/237MM/RT-STER. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 8575495 ↗

Other PLATE, FIXATION, BONE devices

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Sources and updates

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