BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND DYNAFORCE DYNABUNION

    MDR report key: 12128937 · Received July 7, 2021

    Report

    Report Number
    3011421599-2021-00011
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 9, 2021
    Report Date
    July 7, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432028818
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OBSERVED THE ANTI-DRIFT BOLT (ADB) BACKED-OUT AT ROUTINE FOLLOW-UP APPROXIMATELY 7 MONTHS POST-OP. DYNABUNION AS ORIGINALLY IMPLANTED (B)(6) 2020. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 REPLACING THE ADB WITH A CROSSROADS 4.0MM X 34 MM HEADED CANNULATED SCREW AND HIMAX PLUS STAPLE. THE PATIENT IS RECOVERING IN A CAM BOOT TAKING VITAMIN D AND USING A BONE STIMULATOR TO AID WITH FUSION. NON-CONFORMANCE WAS NOT IDENTIFIED BASED ON THE LOTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THE ROOT CAUSE IS UNKNOWN. POTENTIALLY, FORCE FROM WEIGHT-BEARING WITH NORMAL WALKING MOTION CAUSED THE SCREW TO BACK-OUT OR THE SCREW HAD LIMITED CORTICAL BONE PURCHASE WHEN PLACED. SCREW BACK-OUT IS A KNOWN FAILURE MODE OF SCREWS. THE FOLLOWING DEVICES WERE ALSO IMPLEMENTED WITH THE ANTI-DRIFT BOLT: REF: 7100-LP18-L, LN: 501121, QTY: 1, PRODUCT NAME: DYNABUNION PLATE LEFT 18MM. REF: 7118-1818KT, LN: 300196, QTY: 1, PRODUCT NAME: IMPLANT KIT, DYNAFORCE HIMAX 18 X 18 X 18. REF: 1500-3516, LN: 400418, QTY: 1, PRODUCT NAME: MOTOBAND CP - NON-LOCKING SCREWS 3.5MM X 16MM. REF: 15NL-3014, LN: 400017, QTY: 1, PRODUCT NAME: MOTOBAND CP, 3MM X 14MM.

    Description of Event or Problem · 1

    THE REPORTER OBSERVED THE ANTI-DRIFT BOLT (ADB) BACKED-OUT AT ROUTINE FOLLOW-UP APPROXIMATELY 7 MONTHS POST-OP. DYNABUNION AS ORIGINALLY IMPLANTED (B)(6) 2020. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 REPLACING THE ADB WITH A CROSSROADS 4.0MM X 34 MM HEADED CANNULATED SCREW AND HIMAX PLUS STAPLE. THE PATIENT IS RECOVERING IN A CAM BOOT TAKING VITAMIN D AND USING A BONE STIMULATOR TO AID WITH FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024921 MOTOBAND DYNAFORCE DYNABUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 15LP-3534 501113 00815432028818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention