BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 14478311 · Received May 23, 2022

    Report

    Report Number
    3020584246-2022-00002
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 23, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432028788
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6), 2022, THE SURGEON REMOVED DYNABUNION IMPLANTS THAT WERE IMPLANTED (B)(6), 2021. IMPLANTS WERE REMOVED PER PATIENT REQUEST DUE TO PROMINENCE LEADING TO IRRITATION. HARDWARE WAS REMOVED AND NOT REPLACED. UNION WAS PRESENT. IMPLANTS WERE NOT RETURNED FOR ANALYSIS. REVIEW OF PRODUCTION RECORDS DID NOT IDENTIFY NON-CONFORMANCE FOR THE COMPONENTS REMOVED. IN ADDITION TO THE DYNABUNION PLATE, THE FOLLOWING SCREWS AND STAPLE WERE REMOVED AS PART OF THE OVERALL CONSTRUCT: REF: 15LP-3532 LN: 501185 QTY: 1 PRODUCT NAME: DYNABUNION ANTI-DRIFT BOLT, REF: 7118-1818 LN: 501403 QTY: 1 PRODUCT NAME: HIMAX 18MM X 18MM X 18MM, REF: 1500-3518 LN: 400186 QTY: 1 PRODUCT NAME: MOTOBAND NON-LOCKING SCREW 3.5MM X 18MM, REF: 15PL-3518 LN: 400166 QTY: 1 PRODUCT NAME: MOTOBAND POLYAXIAL LOCKING SCREW 3.5MM X 18MM, REF: 15PL-3530 LN: 501040 QTY: 1 PRODUCT NAME: MOTOBAND POLYAXIAL LOCKING SCREW 3.5MM X 30MM.

    Description of Event or Problem · 0

    ON (B)(6), 2022, THE SURGEON REMOVED DYNABUNION IMPLANTS THAT WERE IMPLANTED (B)(6), 2021. IMPLANTS WERE REMOVED PER PATIENT REQUEST DUE TO PROMINENCE LEADING TO IRRITATION. HARDWARE WAS REMOVED AND NOT REPLACED. UNION WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676038 MOTOBAND CP IMPLANT SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 7100-LP18-L 501444 00815432028788

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention