BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND DYNAFORCE DYNABUNION

    MDR report key: 11952200 · Received June 7, 2021

    Report

    Report Number
    3011421599-2021-00009
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 2, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432028825
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON REPORTED THAT THE PATIENT'S ANTI-DRIFT BOLT (ADB) BACKED OUT. THE PATIENT ORIGINALLY HAD LAPIDUS SURGERY WITH DYNABUNION PLATE AND ADB ON (B)(6) 2020. THE PATIENT ALSO HAD A TALONAVICULAR FUSION WITH CROSSROADS STAPLES, PLATES AND SCREWS. THE ADB WAS REPLACED WITH ANOTHER SCREW ON (B)(6) 2021. OTHER HARDWARE WAS NOT REVISED. NON-CONFORMANCE WAS NOT IDENTIFIED BASED ON THE LOTS THAT WOULD CONTRIBUTE TO THESE EVENTS. SCREW BACK-OUT MAY HAVE BEEN DUE TO INADEQUATE FIXATION INTRA-OPERATIVELY. THE FOLLOWING SCREWS AND PLATES WERE IMPLANTED WITH THE ADB AND NOT REVISED OR REMOVED: REF: 7100-LP18-R LN: 501209 QTY: 1 PRODUCT NAME: DYNABUNION PLATE 18MM - RIGHT. REF: 1500-3514 LN: 400032 QTY: 1 PRODUCT NAME: MOTOBAND NON-LOCKING SCREW 3.5MM X 14MM. REF: 1500-3516 LN: 400083 QTY: 1 PRODUCT NAME: MOTOBAND NON-LOCKING SCREW 3.5MM X 16MM. REF: 15PL-3514 LN: 450132 QTY: 1 PRODUCT NAME: MOTOBAND POLYAXIAL LOCKING SCREW 3.5MM X 14 MM. REF: 7118-1818 LN: 501144 QTY: 1 PRODUCT NAME: 18X18X18MM HIMAX

    Description of Event or Problem · 0

    THE SURGEON REPORTED THAT THE PATIENT'S ANTI-DRIFT BOLT (ADB) BACKED OUT. THE PATIENT ORIGINALLY HAD LAPIDUS SURGERY WITH DYNABUNION PLATE AND ADB ON (B)(6) 2020. THE PATIENT ALSO HAD A TALONAVICULAR FUSION WITH CROSSROADS STAPLES, PLATES AND SCREWS. THE ADB WAS REPLACED WITH ANOTHER SCREW ON (B)(6) 2021. OTHER HARDWARE WAS NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847537 MOTOBAND DYNAFORCE DYNABUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 15LP-3536 501167 00815432028825

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention