VA-LCP 02.107.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982029263), received between Aug 18, 2017 and Aug 25, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 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. PATIENT HAD EXPOSED HARDWARE AND WOUND DEHISCENCE REQUIRING DEVICE REMOVAL. IMPLANT(S) INVOLVED: 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM UNKNOWN SCREWS QTY 5.

  Patient problems: Wound Dehiscence

  MAUDE report 22889087 ↗
• MalfunctionJun 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SURGEON ATTEMPTED TO IMPLANT OLECRANON PLATE INTO A PATIENT WITH A PROXIMAL ULNA FRACTURE. AFTER FIXATION WITH K-WIRES AND A 3.5 MM SCREW IN A SHAFT HOLE, HE DISCOVERED THAT ALL OF THE 2.7 MM VA LOCKING SCREWS HE TRIED TO PLACE IN THE PROXIMAL VA LOCKING HOLES WOULD NOT LOCK. THE SURGEON USED GOOD TECHNIQUE, DRILLING WITH THE APPROPRIATE DRILL BIT AND USING THE "CONE" SIDE OF THE VARIABLE ANGLE 2.0 MM DRILL GUIDE TO ENSURE THE SCREW WAS PLACED WITHIN THE 30 DEGREE LOCKING CONE. SURGEON ATTEMPTED TO PLACE THREE LOCKING SCREWS IN DIFFERENT HOLES BEFORE DECLARING THAT THE LOCKING HOLES ON THE PLATE WERE DAMAGED BEFORE THE CASE BEGAN. THE SURGEON REMOVED THE PLATE FROM THE PATIENT'S BONE AND INSTEAD IMPLANTED A 4 HOLE VA-LCP OLECRANON PLATE. NO MATERIALS WERE BROKEN INTRAOPERATIVELY SO NO FRAGMENTS WERE GENERATED. THERE WAS A 20 MINUTES OF SURGICAL DELAY. THE ISSUE WAS A FAILURE OF LOCKING MECHANISM. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615691 ↗
• MalfunctionMay 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNTHES 2.7 VA LOCKING SCREW WOULD NOT LOCK INTO THE 2.7/3.5 VA OLECRANON PLATE. THERE WAS AN OLECRANON FRACTURE REPORTED. THERE WAS A SURGICAL DELAY OF 120 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES OR OUTCOMES. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP OLECRANON PL 2H/RT/90 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864785 ↗
• MalfunctionAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, ORIF OF RIGHT OLECRANON WAS BEING PERFORMED AS A REVISION PROCEDURE DUE TO THE PATIENT EXPERIENCING A FALL. WHILE IMPLANTING A VA-LCP OLECRANON PLATE, THE SURGEON FOUND THAT THE TWO MOST PROXIMAL VA HOLES WOULD NOT ENGAGE WITH THE LOCKING SCREW. THE SCREW WOULD JUST SPIN IN PLACE. THE PLATE WAS SWAPPED OUT FOR ANOTHER OF THE SAME MODEL, AND THE ISSUE PERSISTED. ALL INSTRUMENTS WERE USED ACCORDING TO THE TECHNIQUE GUIDE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147340 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT HAD A DISPLACED COMMINUTED ACUTE OLECRANON FRACTURE RIGHT ELBOW WHICH WAS FIXED WITH A SYNTHES OLECRANON LOCKING PLATE, 5 SCREWS IN THE SHAFT WITH BICORTICAL FIXATION, AND 4 LOCKING UNICORTAL SCREWS IN THE PROXIMAL SEGMENT. ON OR ABOUT (B)(6) 2016, SYNTHES ANNOUNCED A RECALL OF THE SYSTEM DUE TO THE DISCOVERY THAT THE SYSTEM WAS DEFECTIVE AND COULD CAUSE THE RADIAL STEM TO LOOSEN POST-OPERATIVELY AT THE STEM BONE INTERFACE. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION DUE TO PAIN, RIGHT ELBOW RETAINED HARDWARE, OSTEOLYSIS SECONDARY TO LOOSE IMPLANT - RADIAL HEAD, AND FAILED RADIAL HEAD ARTHROPLASTY. OPERATIVE FINDINGS DISCOVERED HYPERTHROPY AND SYNOVITIS, CHONDROMALACIS OF CAPITELLUM GRADE II, GRADE II WITH PERIPHERAL SPUR. THE OLECRANON FRACTURE HEALED WITHOUT ANY LOOSENING OR EVIDENCE OF ANY OSTEOLYSIS AROUND OLECRANON PLATE AND SCREWS. THIS IS REPORT 1 OF 12 FOR (B)(4).

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 14085287 ↗
• MalfunctionSep 7, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021, WHILE INSERTING A 2.7MM VA LOCKING SCREW INTO A 2.7MM VA OLECRANON PLATE, METAL SHAVINGS WERE CREATED BETWEEN THE SCREW AND THE LOCKING HOLES. FRAGMENTS WERE GENERATED AND WAS REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVER: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435468 ↗
• MalfunctionJan 26, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A PROCEDURE OPEN REDUCTION INTERNAL FIXATION DISTAL HUMERUS AND OLECRANON WAS PERFORMED. A RIGHT-SIDE OLECRANON PLATE MAY HAVE BEEN IMPLANTED INTO A LEFT ELBOW. WHEN RESTOCKING IMPLANTS USED IN THE CASE A FEW DAYS LATER IT WAS NOTICED THAT THE RIGHT SIDE PLATE WAS MISSING EVEN THOUGH WE HAD BILLED FOR, AND RE-ORDERED A PLATE FOR THE LEFT SIDE. THE SURGERY WAS ON THE LEFT ARM, BUT THERE WAS A RIGHT SIDE PLATE MISSING. THE SURGEON COMMENTED THAT THE X-RAY CONFIRMED A RIGHT-SIDED PLATE WAS INDEED IMPLANTED ON THE LEFT OLECRANON. THE SURGEON WAS NOT PLANNING ANY FURTHER TREATMENTS, SAYING THE PLATE FIT THE BONE WELL AND IS IN A SATISFACTORY POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED AND NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229326 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A OPEN REDUCTION INTERNAL FIXATION FOR A ACUTE FRACTURE OF THE RIGHT OLECRANON ON (B)(6) 2018. THE PATIENT WENT TO SURGEONS OFFICE ON (B)(6) 2018 WITH A PORTION OF THE PLATE PROTRUDING THROUGH THE SKIN. SURGEON STATED HE THOUGHT THE SPLIT RUBBING ON THE PLATE IS WHAT WORE OUT THE SKIN. THE PATIENT UNDERWENT SURGERY THE SAME DAY TO REMOVE THE HARDWARE. THE FRACTURE APPEARED HEALED. NO NEW FIXATION WAS NEEDED ACCORDING TO THE SURGEON. ALL HARDWARE (1 PLATE AND 6 SCREWS) WAS REMOVED INTACT WITHOUT DELAY. CONCOMITANT PRODUCT: QTY 6, UNKNOWN SCREW(S) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7430999 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort; No Code Available

  MAUDE report 6804058 ↗

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