VA-LCP 02.107.512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982029546), received between Mar 7, 2019 and Mar 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K120070); they may or may not involve this specific model.

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.

• InjuryMar 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) EXTRA-ARTICULAR PROXIMAL ULNA PLATE DUE TO A BROKEN PLATE WITH A NONUNION ULNA. THE PLATE WAS REMOVED. THE FOUR (4) 2.7MM LOCKING SCREWS, SEVEN (7) 3.5MM LOCKING SCREWS AND TWO (2) 3.5MM CORTEX SCREWS WERE ALSO REMOVED. NO FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE; IT WAS REMOVED EASILY WITH NO ADDITIONAL INTERVENTION NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL PROCEDURE WAS DONE ON (B)(6) 2012. A SECOND PROCEDURE WAS DONE ON (B)(6) 2016, WHICH WAS A REVISION OF AN EARLIER CASE WITH THE PLATE THAT WAS REMOVED ON (B)(6) 2019. CONCOMITANT DEVICES REPORTED: 2.7MM LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY 4), 3.5MM LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY 7), 3.5MM LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY 2). THIS REPORT IS FOR A VA-LCP EXTRA-ARTICULAR PROXIMAL ULNA PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8400365 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes