BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCALL

    MDR report key: 21384928 · Received February 14, 2025

    Report

    Report Number
    3012086398-2025-00001
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Manufacturer
    BODYCAD LABORATORIES INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS CUSTOM-MADE ORTHOPEDIC IMPLANT WAS USED IN A SURGERY PERFORMED ON (B)(6) 2024. DESPITE SOME INTRAOPERATIVE CHALLENGES WITH THE CUTTING GUIDE, THE SURGERY WAS SUCCESSFULLY COMPLETED. HOWEVER, POST-OPERATIVE COMPLICATIONS HAVE NOW BEEN REPORTED. THE FINAL CONSTRUCTION DID NOT HOLD, LEADING TO PLATE COLLAPSE. THREE DISTAL SCREWS AND THE MOST PROXIMAL SCREW HAVE DISENGAGED. PSEUDARTHROSIS HAS BEEN OBSERVED, INDICATING A LACK OF BONE HEALING AT THE SURGICAL SITE. A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151812 ONCALL ONCALL HRS BODYCAD LABORATORIES INC 012-000

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Unknown Required Intervention