BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND

    MDR report key: 11072281 · Received December 24, 2020

    Report

    Report Number
    3011421599-2020-00016
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 24, 2020
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432026364
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT ROUTINE FOLLOW-UP THE SURGEON NOTED THAT THE MPJ PLATE WAS BROKEN AT THE FUSION SITE APPROXIMATELY 3 MONTHS AFTER THE INITIAL SURGERY. THE PATIENT WAS NON-WEIGHT BEARING FOR 2 WEEKS THEN WEIGHT BEARING FOR 8 WEEKS. THE SURGEON GOT A CT SCAN AND DETERMINED FUSION WOULD NOT LIKELY OCCUR. THE SURGEON REMOVED THE DEVICE AND PLACE NON-CROSSROADS DEVICES ON (B)(6) 2020. THE IMPLANT WAS REMOVED WITHOUT COMPLICATION. REVIEW OF PRODUCT RECORDS CONFIRM ALL COMPONENTS CONFORM TO ASTM F136 TI-6AL-4V TITANIUM ALLOY. NO NONCONFORMANCE WAS IDENTIFIED. ADDITIONAL COMPONENTS USED IN THIS CASE: 7118-1818KT, 300218, 18X18 HIMAX STAPLE WITH INST KIT - STERILE THE STAPLE WAS INTACT ACROSS THE BROKEN PLATE.

    Description of Event or Problem · 1

    AT ROUTINE FOLLOW-UP THE SURGEON NOTED THAT THE MPJ PLATE WAS BROKEN AT THE FUSION SITE APPROXIMATELY 3 MONTHS AFTER THE INITIAL SURGERY. THE PATIENT WAS NON-WEIGHT BEARING FOR 2 WEEKS THEN WEIGHT BEARING FOR 8 WEEKS. THE SURGEON GOT A CT SCAN AND DETERMINED FUSION WOULD NOT LIKELY OCCUR. THE SURGEON REMOVED THE DEVICE WITHOUT COMPLICATION AND PLACE NON-CROSSROADS DEVICES ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535475 MOTOBAND PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 7150-0018 500991 00815432026364

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention