BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 12964836 · Received December 8, 2021

    Report

    Report Number
    3011421599-2021-00014
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Report Date
    December 8, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432028870
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. POTENTIALLY, FORCE FROM WEIGHT-BEARING WITH NORMAL WALKING MOTION CAUSED THE SCREW TO BACK-OUT. SCREW BACK-OUT IS A KNOWN FAILURE MODE OF SCREWS. REFER TO LOT NUMBER BELOW FOR ADDITIONAL COMPONENTS OF THE CONSTRUCT. REF: 7100-LP18-R, LN: 501122, QTY: 1, PRODUCT NAME: DYNABUNION RIGHT PLATE 18MM. REF: 7118-1814KT, LN: 300277, QTY: 1, PRODUCT NAME: 18X18X14MM HIMAX CLIP. REF: 15LP-3530, LN: 501163, QTY: 1, PRODUCT NAME: DYNABUNION ANTIDRIFT BOLT 30MM. REF: 15NL-3016, LN: 400118, QTY: 1, PRODUCT NAME: 3.0 X 16MM NON-LOCKING SCREW. REF: 1500-3514, LN: 400076, QTY: 1, PRODUCT NAME: 3.5 X 14MM NON-LOCKING SCREW. REF: 1500-3514, LN: 400007, QTY: 1, PRODUCT NAME: 3.5 X 14MM NON-LOCKING SCREW.

    Description of Event or Problem · 0

    THE SURGEON SUBMITTED A CASE SERIES OF DYNABUNION SYSTEM. THE ANTI-DRIFT BLOT HAS BACKED OUT AS SHOWN IN THE 6-WEEK X-RAY. THE SCREW HEAD PROMINENT ABOVE THE PLATE. THE PATIENT WAS ASYMPTOMATIC AND REVISION SURGERY WAS NOT SCHEDULED AT THE TIME OF THE REPORT. THE SURGEON REPORTED AT A LATER DATE THAT THE SYSTEM WAS REMOVED AFTER A PERIOD OF NON-WEIGHT BEARING. THE PATIENT STATUS AFTER THE REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858009 MOTOBAND CP IMPLANT SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 7100-LP18-R 501122 00815432028870

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention