VA-LCP 02.127.261Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982043689), received between Mar 28, 2023 and Mar 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, ONE OF THE HOLES OF THE VA PROXIMAL TIBIA PLATE STRIPPED DUE TO THE SURGICAL TECHNOLOGIST POTENTIALLY OVER TIGHTENING THE CONNECTING SCREW OF THE TARGETER. ANOTHER PLATE WAS SELECTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO COMPLAINTS AGAINST THE TARGETER, ONLY THE PLATE WHICH HOLE STRIPPED OUT. THERE WERE NO ALLEGATIONS ON THE DEVICE ITSELF. NO ADVERSE EVENTS OCCURRED. SURGICAL DELAY OF 5 MINUTES. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 3.5 VA PROX TIB PL SMALL BEND/14H/237/LT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630950 ↗