BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 8442068 · Received March 21, 2019

    Report

    Report Number
    3011421599-2018-00006
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    October 23, 2018
    Report Date
    November 21, 2018
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    HRS
    UDI-DI
    00815432023684
    PMA / PMN Number
    K160300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATE WAS USED IN COMBINATION WITH A NITINOL CLIP IMPLANT, AND TOGETHER FUNCTIONED AS ONE TOTAL CONSTRUCT, IN ORDER TO PROVIDE COMPRESSION TO BETTER FACILITATE THE FUSION PROCESS. ONE OF THE CLIPS USED HAS ALSO BEEN CONFIRMED TO HAVE EXPERIENCED MECHANICAL FAILURE. THE CLIPS THAT WERE USED ARE LISTED BELOW: PART NUMBER: 7115-1515KT LOT NUMBER: 500145; PART NUMBER: 7115-1515, LOT NUMBER: 500173.

    Description of Event or Problem · 1

    DATE OF INITIAL SURGERY WAS (B)(6) 2018. THE HARDWARE WAS REMOVED ON (B)(6) 2018 AND THE SITE WAS REVISED. THE PLATE AND ONE NITINOL CLIP IMPLANT HAVE BEEN CONFIRMED TO HAVE EXPERIENCED MECHANICAL FAILURE. NO X-RAYS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234824 MOTOBAND CP IMPLANT SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE HRS CROSSROADS EXTREMITY SYSTEMS LLC 500143 00815432023684

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention