NA 02.118.544Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982039507), received between Aug 6, 2018 and Aug 6, 2018 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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.

• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE ON (B)(6) 2018, DUE TO PAIN. DURING REMOVAL OF THE PLATE, THE SCREWDRIVER WOULD NOT DISENGAGE FROM THE SCREWDRIVER HANDLE. ANOTHER SCREWDRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A TEN (10) MINUTE DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT WILL ADDRESS THE COMPLAINT ABOUT THE VA-LCP OLECRANON PLATE THAT WAS REMOVED DUE TO PAIN. THE SCREWDRIVER BLADE AND SCREWDRIVER HANDLE HAVE BEEN CAPTURED UNDER RELATED COMPLAINT NUMBER (B)(4). THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7753629 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. 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