VA-LCP 02.107.408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982029423), received between Dec 29, 2017 and Aug 6, 2019 — classified as 2 injuries.

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

• InjuryAug 6, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE DUE TO BREAKAGE AT THE 3RD MOST PROXIMAL SCREW HOLE. THE PLATE AND UNKNOWN SCREWS WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. BROKEN FRAGMENTS WERE COMPLETELY REMOVED. THERE WAS A REMOVAL THEN REIMPLANTATION OF A LONGER PLATE, SAME MODEL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN VARIABLE ANGLE LOCKING SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: UNKNOWN), UNKNOWN CORTEX SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8866380 ↗
• InjuryDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) EXTRA-ARTICULAR PROXIMAL ULNA PLATE APPROXIMATELY 6 MONTHS PRIOR TO REMOVAL. PATIENT PRESENTED WITH PUS DRAINAGE FROM THE INCISION AND WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED THE VA LCP EXTRA-ARTICULAR PROXIMAL ULNA PLATE, THREE (3) 3.5MM CORTICAL SCREWS, TWO (2) 3.5MM LOCKING SCREWS, AND SIX (6) 2.7MM VA LOCKING SCREWS. PATIENT WAS REVISED TO ANTIBIOTIC BEADS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7155176 ↗

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