BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 13980755 · Received April 1, 2022

    Report

    Report Number
    3020584246-2022-00001
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON IDENTIFIED A BROKEN HIMAX STAPLE IN A MOTOBAND CP STAPLE PLATE CONSTRUCT AT ROUTINE FOLLOW-UP. THE DEVICES WERE EXPLANTED AND RETURNED TO CROSSROADS. EXAMINATION OF THE PLATE AND STAPLE FRACTURE WERE CONSISTENT WITH FATIGUE FRACTURE.

    Description of Event or Problem · 0

    THE SURGEON IDENTIFIED A BROKEN HIMAX STAPLE IN A MOTOBAND CP STAPLE PLATE CONSTRUCT AT ROUTINE FOLLOW-UP. THE DEVICES WERE EXPLANTED AND RETURNED TO CROSSROADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492239 MOTOBAND CP IMPLANT SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 270306 20202591

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention