VA-LCP 02.117.601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982036940), received between Oct 28, 2020 and Mar 13, 2024 — 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.

• MalfunctionMar 13, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON 26-FEBRUARY-2024, THE PLATES IN QUESTION HAD HOLES THAT WERE STRIPPED OUT AND WOULDN¿T HOLD LOCKING SCREWS. THE ISSUE WAS DISCOVERED PRE-OP, THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 1H/RT/72MM-SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897127 ↗
• MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE SURGEON WAS PERFORMING A DUAL PLATING OF THE DISTAL HUMERUS, AND MULTIPLE VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK INTO EACH PLATE. STANDARD OPERATING PROCEDURE WAS PERFORMED FOR EACH SCREW THAT CONSISTED OF USING A CONE GUIDE FOR DRILLING FOLLOWED BY MEASURING AND INSERTION OF THE SCREW WITH TORQUE LIMITER. THERE WERE NO PATIENT OUTCOMES REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 15 MINUTES. THIS REPORT INVOLVES ONE 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 1H/RT/72MM-SHORT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836332 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, THAT PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION AND 1 BROKEN 60MM LENGTH VA LOCKING SCREW. ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, SEVEN (7) VA LOCKING SCREWS AND ONE (1) CORTEX SCREW AND ONE (1) VA LCP DISTAL HUMERUS PLATE WERE SUCCESSFULLY EXPLANTED. THERE WAS A FRAGMENT OF THE SHAFT AND THE SCREWHEAD BUT IT WAS REMOVED EASILY WITHOUT ADDED TIME. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10752236 ↗

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