VA-LCP 02.118.204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982038340), received between Oct 31, 2018 and Oct 27, 2021 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PROCEDURE, THE SURGEON FOUND THE ANTEROLATERAL PLATE WAS TOO BULKY AND NOT ABLE TO LOCK THE SCREW. THE SCREW APPEARED TO BE AT A DIFFERENT ANGLE THAN THE NOMINAL ANGLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA ANTEROLAT DSTL TIB PL/6 H/RT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708058 ↗
• 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 1 OF 3 FOR (B)(4).

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

  MAUDE report 8025744 ↗