VA-LCP 02.117.504Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982036780), received between Jan 8, 2019 and Mar 13, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PLATES WERE IMPLANTED IN THE PATIENT, THE LOCKING SCREWS DID NOT LOCK IN 1-2 HOLES OF THE PL AND MEDIAL PLATES SO THOSE PLATE HOLES WERE NOT FILLED. THE SURGEON INITIALLY USED A VA GUIDE BUT LATER USED A NON LOCKING DRILL GUIDE. UNSURE IF IT¿S BECAUSE HE USED A METAPHYSEAL SCREW FIRST TO SUCK THE PLATE DOWN, AND THEN CHANGED FOR A VAL. WE¿VE HAD ISSUES WITH THIS PLATE NOT LOCKING, SURGEON DID NOT WANT PATIENT TO BE CHARGED. WHILE INSERTING CORTICAL SCREWS AND A 7.3 CANNULATED FOR THE OLECRANON OSTEOTOMY HE ALSO COMPLAINED OF THE SCREWDRIVER HEADS BEING STRIPPED OR WARPED. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA MEDL DSTL HUM PL 4H/LT/108-LG. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897644 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 15 OF 17 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14091257 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON UNKNOWN DATE, A PATIENT UNDERWENT REVISION WITH A 3.5 MM DISTAL HUMERUS EXTRA ARTICULAR PLATE 8 HOLES AND 8 SCREWS DUE TO NON-UNION. THE PATIENT HAD HARDWARE REMOVAL OF THE FOLLOWING DEVICES: TWO (2) VARIABLE ANGLE ELBOW PLATE, ONE (1) UNKNOWN 3.5 LOCKING SCREW, FIVE (5) UNKNOWN 3.5 CORTEX SCREW, TWO (2) UNKNOWN 2.7 MM METAPHYSEAL SCREW , FOUR (4) UNKNOWN 2.7 VA LOCKING SCREW, AND ONE (1) UNKNOWN 2.7 CORTEX SCREW. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THE REMOVAL AND PROCEDURE WENT WELL. PATIENT OUTCOME WAS FINE. THIS COMPLAINT INVOLVES SEVEN(7) DEVICES. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP MEDL DSTL. THIS REPORT IS 1 OF 7 FOR (B)(4).

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

  MAUDE report 8226406 ↗

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