BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 12954659 · Received December 7, 2021

    Report

    Report Number
    3011421599-2021-00012
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Report Date
    December 7, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON IDENTIFIED A BROKEN PLATE AT ROUTINE FOLLOW-UP. AT THAT TIME, REVISION SURGERY WAS NOT PLANNED. AT SOME POINT, THE SURGEON PERFORMED REVISION SURGERY AND SALES REPRESENTATIVE RETURNED THE EXPLANTS FOR ANALYSIS. LOT HISTORY RECORDS (LHR'S) OF THE PLATE WAS REVIEWED. NON-CONFORMANCE WAS NOT IDENTIFIED BASED ON THE LOTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. EXAMINATION OF THE PLATE AND STAPLE FRACTURE WERE CONSISTENT WITH FATIGUE FRACTURE.

    Description of Event or Problem · 0

    THE SURGEON IDENTIFIED A BROKEN PLATE AT ROUTINE FOLLOW-UP. AT THAT TIME, REVISION SURGERY WAS NOT PLANNED. AT SOME POINT, THE SURGEON PERFORMED REVISION SURGERY AND SALES REPRESENTATIVE RETURNED THE EXPLANTS FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845737 MOTOBAND CP IMPLANT SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 260266 104235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention