VA-LCP 02.118.307Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982038760), received between Oct 31, 2018 and Oct 2, 2020 — classified as 2 injuries.

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.

• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. ONE (1) 2.7 MM VARIABLE ANGLE LOCKING SCREW 40MM WAS FOUND BROKEN DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT THE 2.7 MM VARIABLE ANGLE LOCKING SCREW 4MM. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP DISTAL TIBIA T-PLATE/6 HOLES THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TOTAL 23 DEVICES. (B)(4) REPORTS 10 DEVICES, ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10620518 ↗
• 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 2 OF 3 FOR (B)(4).

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

  MAUDE report 8025653 ↗