VA-LCP 02.107.204SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982029294), received between Dec 12, 2017 and Aug 2, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, ORIF OF RIGHT OLECRANON WAS BEING PERFORMED AS A REVISION PROCEDURE DUE TO THE PATIENT EXPERIENCING A FALL. WHILE IMPLANTING A VA-LCP OLECRANON PLATE, THE SURGEON FOUND THAT THE TWO MOST PROXIMAL VA HOLES WOULD NOT ENGAGE WITH THE LOCKING SCREW. THE SCREW WOULD JUST SPIN IN PLACE. THE PLATE WAS SWAPPED OUT FOR ANOTHER OF THE SAME MODEL, AND THE ISSUE PERSISTED. ALL INSTRUMENTS WERE USED ACCORDING TO THE TECHNIQUE GUIDE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/RT/116MM-STER. THIS IS REPORT 1 OF 3 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147351 ↗
• MalfunctionAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, ORIF OF RIGHT OLECRANON WAS BEING PERFORMED AS A REVISION PROCEDURE DUE TO THE PATIENT EXPERIENCING A FALL. WHILE IMPLANTING A VA-LCP OLECRANON PLATE, THE SURGEON FOUND THAT THE TWO MOST PROXIMAL VA HOLES WOULD NOT ENGAGE WITH THE LOCKING SCREW. THE SCREW WOULD JUST SPIN IN PLACE. THE PLATE WAS SWAPPED OUT FOR ANOTHER OF THE SAME MODEL, AND THE ISSUE PERSISTED. ALL INSTRUMENTS WERE USED ACCORDING TO THE TECHNIQUE GUIDE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/RT/116MM-STER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147343 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIGHT PROXIMAL ULNA ON (B)(6) 2017. AFTER THAT THE PATIENT COMPLAINED OF STIFFNESS AND SO THE SURGEON HAD TO DO THE REVISION SURGERY FOR REMOVAL OF THE PLATE AND SCREWS. THE PLATE AND THE SCREWS WERE INTACT AND THERE WAS NO MALFUNCTION WITH THE DEVICE. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) 2.7 MM/3.5 MM VA-LCP OLECRANON PLATE. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 7108493 ↗

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