VA-LCP 02.107.308SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982029393), received between May 29, 2019 and Jun 6, 2022 — 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.

• InjuryJun 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 2.7MM VA LOCKING SCREWS OF VARIOUS LENGTHS BROKE DURING REMOVAL. THERE IS REPORTED SURGICAL DELAY OF 30 MINUTES. THIS COMPLAINT INVOLVES ONE (1) DEVICE VA-LCP OLECR PL 2.7/3.5 LE 8HO L169 SST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 14602757 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) OLECRANON PLATE, ONE (1) METAPHYSEAL SCREW, FIVE (5) CORTEX SCREWS, AND SIX (6) VARIABLE ANGLE (VA) LOCKING SCREWS. THE PATIENT HAD A MALUNION, WOUND NOT CLOSING, INFECTION, AND NONUNION OF HER LEFT ELBOW OLECRANON PLATE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) OLECRANON PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 8650359 ↗

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