VA-LCP 02.107.306Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982029379), received between Sep 23, 2019 and Aug 25, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 38 PATIENTS THAT WERE IMPLANTED WITH ELBOW PLATES DEVICE GROUPS - VA-LCP OLECRANON AND VA-LCP PROXIMAL OLECRANON PLATES IN STAINLESS STEEL. IMPLANTATION WAS BETWEEN (B)(6) 2025 TO (B)(6) 2025. SUBJECT ID 6: 57-YEAR-OLD MALE PATIENT HAD EXPOSED HARDWARE AND AN OPEN WOUND REQUIRING DEVICE REMOVAL. IMPLANT(S) INVOLVED: 2.7MM/3.5MM VA-LCP OLECRANON PL 6H/LT/142MM (QTY 1). UNKNOWN SCREWS (QTY 6).

  Patient problems: Post Operative Wound Infection

  MAUDE report 22889055 ↗
• InjuryApr 1, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 2.7MM/3.5MM VARIABLE ANGLE LCP OLECRANON PLATE BROKE AND NEEDED TO BE REVISED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) PLATE. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13978672 ↗
• InjuryMar 30, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY WAS REQUIRED ON (B)(6) 2021 BECAUSE ITEM 02.107.306 BROKE. NEW PLATE AND SCREWS WERE IMPLANTED SUCCESSFULLY THIS COMPLAINT INVOLVES ONE (1) DEVICE 2.7/3.5 VA-LCP OLECRANON PL 6H/LT/142. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

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

  MAUDE report 13953223 ↗
• InjuryDec 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A BROKEN OLECRANON PLATE. TWO (2) 3.5 CORTEX SCREWS, TWO (2) 3.5 LOCKING SCREWS, SEVEN (7) 2.7 LOCKING SCREWS, AND ONE (1) OLECRANON PLATE WERE ALL REMOVED. THE PATIENT WAS SEEN WITH ELBOW PAIN, X-RAY TAKEN REVEALED BROKEN PLATE. SURGERY WAS PLANNED TO REMOVE PLATE AND REVISE. THE PLATE AND SCREWS WERE REMOVED SUCCESSFULLY AND A NEW PLATE AND SCREWS IMPLANTED. THERE WERE NO ALLEGATIONS AGAINST THE SCREWS. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN 3.5MM CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2), UNKNOWN 3.5MM LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2), UNKNOWN 2.7MM LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 7). THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9507152 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT HARDWARE REMOVAL OF OLECRANON DUE TO INFECTION AND INFLAMMATION. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TITANIUM FUSION PLATE 3 HOLES, ONE (1) LOCKING COMPRESSION PLATE 10 HOLES, 0NE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE 6 HOLES, TWO (2) CORTICAL SCREWS, ONE (1) LOCKING SCREW, EIGHT (8) VARIABLE ANGLE LOCKING SCREWS, THREE (3) 2.7 CORTEX SCREWS AND TWO (2) CORTEX SCREWS WERE REMOVED. ALL HARDWARE WAS INTACT. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) 2018, WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF) FOR A GUNSHOT WOUND. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS COMPLETE AND STABLE. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9105378 ↗

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