VA-LCP 02.118.111SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982038135), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 injury.

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.

• InjurySep 10, 2021Adverse 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 A HARDWARE REMOVAL OF AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS DUE TO INFECTION AND NON-UNION. THE SURGEON REMOVED AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS ALONG WITH SOME CANNULATED SCREWS FROM THE DISTAL TIBIA. THE REASON FOR REMOVAL IS AN INFECTED NON UNION. THERE WERE NO ALLEGATIONS AGAINST THE DEVICES. THE SURGEON DECIDED NOT TO TAKE ALL THE HARDWARE OUT THAT DAY AND BRING THE PATIENT BACK AT A LATER DATE TO REMOVE THE REST OF IT. A DISTAL TIBIA PLATE AND SCREW REMAINED IN THE PATIENT. IT WAS ULTIMATELY DECIDED NOT TO REMOVE ANY MORE OF THE HARDWARE BECAUSE THE INFECTION WAS SUBSIDING. THE SURGEON PUT A CIRCULAR FIXATOR ON THE ANKLE FOR DEFINITIVE FIXATION. THIS PRODUCT WAS IMPLANTED IN (B)(6) 2020. THIS REPORT IS FOR (1) 2.7/3.5MM VA-LCP ANTEROMEDIAL DISTAL TIBIA PL/12 H/LT-STER. THIS IS REPORT 1 OF 17 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 12453540 ↗