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VA-LCP 02.107.204Recalls & reported problems

Synthes GmbH · 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/RT/116MM · Class 2 · Implant

All models of VA-LCP (256)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982029287), received between Mar 30, 2018 and Sep 25, 2026 — classified as 3 injuries, 3 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Device-Device Incompatibility3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Pain3
  • Bone Fracture(s)1
  • Muscular Rigidity1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2026Device-Device Incompatibility

    It was reported that there was rust on items. The items are not able to be sterilized. The Locking holes in plates are compromised/did not lock in surgeries. There was no patient harm or surgical delay.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50900180 ↗
  • MalfunctionSep 25, 2026Device-Device Incompatibility

    It was reported that there was rust on items. The items are not able to be sterilized. The Locking holes in plates are compromised/did not lock in surgeries. There was no patient harm or surgical delay.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50900179 ↗
  • InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2022 REMOVAL OF HARDWARE DUE TO PAIN. SCREWS AND PLATES . NO SURGICAL DELAYED DUE TO THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED BUT IS UNKNOWN IF THEY WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP OLECRANON PL 4H/RT/116 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: Pain

    MAUDE report 15361717 ↗
  • MalfunctionSep 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED ON THAT (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE VA LOCKING SCREW WOULD NOT LOCK INTO PLATE HOLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO(2) DEVICES. THIS REPORT IS FOR (1) 2.7/3.5 VA-LCP OLECRANON PL 4H/RT/116. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12421634 ↗
  • InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ADDITIONAL EVENT DESCRIPTION LEGAL AND MEDICAL RECORDS RECEIVED. ON OR ABOUT (B)(6) 2019, PATIENT EXPERIENCED DISPLACEMENT, PAIN, STIFFNESS OF RIGHT ELBOW, DISPLACED FRACTURE RIGHT, REMOVAL OF RADIUS HEAD IMPLANT, REMOVAL OF HARDWARE OF THE OLECRANON AS WELL AS THE RADIAL HEAD, LYSIS OF ADHESION AND DEBRIDEMENT. PATIENT PRESENTS DUE TO CONTINUED STIFFNESS OF THE RIGHT ELBOW AND WORSENING RIGHT ELBOW PAIN. FEELS LIKE OCCUPATIONAL THERAPY WAS VIGOROUS AND CAUSE ELBOW PAIN TO OCCUR AFTER SURGERY WHICH NEVER RESOLVED. PRIOR TO THAT SESSION SHE REPORTS SHE HAD WRIST PAIN AND NUMBNESS WHICH THEN RADIATED INTO THE ELBOW. CT SCAN OF RIGHT ELBOW WAS DONE FOR REVIEW. REPORTS OCCASIONAL NUMBNESS IN THE FINGER. ALSO HAS PERSISTENT NECK PAIN AND STIFFNESS. THE PATIENT PRESENTS WITH COMPLAINTS OF GRADUAL ONSET. THIS COMPLAINT INVOLVES (1) DEVICE. RELATED PRODUCT COMPLAINT: (B)(4).

    Patient problems: Bone Fracture(s); Muscular Rigidity; Pain

    MAUDE report 11251964 ↗
  • InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ELBOW AND TIBIA ON (B)(6) 2017. ON UNKNOWN DATE PATIENT REPORTED EXPERIENCING PAIN AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. HARDWARE REMOVED INCLUDED ONE (1) 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) OLECRANON PLATE, SIX (6) LOCKING SCREWS, TWO (2) CORTEX SCREWS, ONE (1) 4.5MM LCP PROXIMAL TIBIA PLATE, SEVEN (7) LOCKING SCREWS, AND TWO (2) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) VA LCP OLECRANON PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Patient problems: Pain

    MAUDE report 7387065 ↗

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

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

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