VA-LCP 02.117.404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982036568), received between Jul 5, 2018 and Feb 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2019. A VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) MEDIAL PLATE BROKE INTO TWO (2) PIECES WITHIN A MONTH OF SURGERY WHILE THE OTHER PLATES STAYED INTACT AND NO SCREWS WERE BROKEN. SURGEON REPLACED THE MEDIAL PLATE AND ADDED UNKNOWN SCREWS TO THE LATERAL PLATE. SURGEON PERFORMED INITIAL SURGERY ON (B)(6) 2018 ON THE DISTAL HUMERUS OF A PATIENT. DURING SURGERY THE SURGEON PLACED AN OLECRANON PLATE, MEDIAL PLATE, AND LATERAL PLATE ON THE PATIENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE: SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN); OLECRANON PLATE (PART/LOT UNKNOWN, QUANTITY 1); LATERAL PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A MEDIAL PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8370966 ↗
• InjuryJul 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ONE (1) VARIABLE ANGLE-LOCKING COMPRESSION PLATE MEDIAL DISTAL HUMERUS PLATE 4 HOLES AND ONE (1) VA-LCP MEDIAL DISTAL HUMERUS PLATE 5 HOLES ON AN UNKNOWN DATE IN (B)(6) 2017. THE PATIENT FELL ON AN UNKNOWN DATE IN (B)(6) 2018 AND BROKE THE VA-LCP MEDIAL DISTAL HUMERUS PLATE 4 HOLES. ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION. THE SURGEON REMOVED BOTH PLATES AND REPLACED THEM WITH THE SAME KIND OF PLATE BUT TWO (2) HOLES LONGER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: VA-LCP MEDIAL DISTAL HUMERUS PLATE 5 HOLES (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TRAUMA DEVICE (PART: UNKNOWN, LOT UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 4H/RT/108MM-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7664708 ↗

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