BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND DYNAFORCE DYNABUNION

    MDR report key: 11961667 · Received June 8, 2021

    Report

    Report Number
    3011421599-2021-00010
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    March 24, 2021
    Report Date
    June 8, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTS THAT THE ANTI-DRIFT BOLT BACKED OUT AND WAS ASYMPTOMATIC ON (B)(6) 2021. THE SCREW CONTINUED TO BACK-OUT AND BECAME SYMPTOMATIC ON (B)(6) 2021. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE THE ANTI-DRIFT BOLT WAS REMOVED AND REPLACED. PATIENT RECOVERED AND RESOLVED SYMPTOMS ASSOCIATED WITH LAPIDUS PROCEDURE. PATIENT REPORTS ANKLE POPPING AND 5TH TOE SPASMS LIKELY UNRELATED. 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: 1500-3518 LN: 400074 QTY: 1 PRODUCT NAME: MOTOBAND CP NON-LOCKING SCREWS 3.5MM X 18MM. REF: 7118-1818KT LN: 300288 QTY: 1 PRODUCT NAME: IMPLANT KIT, DYNAFORCE HIMAX, 18MM X 18MM X 18MM. REF: 1500-3514 LN: 400147 QTY: 2 PRODUCT NAME: MOTOBAND CP - NONLOCKING SCREWS 3.5MM X 14MM. REF: 7100-LP18-R LN: 501209 QTY: 1 PRODUCT NAME: DYNABUNION PLATE RIGHT 18MM.

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT THE ANTI-DRIFT BOLT BACKED OUT AND WAS ASYMPTOMATIC ON (B)(6) 2021. THE SCREW CONTINUED TO BACK-OUT AND BECAME SYMPTOMATIC ON (B)(6) 2021. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE THE ANTI-DRIFT BOLT WAS REMOVED AND REPLACED. PATIENT RECOVERED AND RESOLVED SYMPTOMS ASSOCIATED WITH LAPIDUS PROCEDURE. PATIENT REPORTS ANKLE POPPING AND 5TH TOE SPASMS LIKELY UNRELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855040 MOTOBAND DYNAFORCE DYNABUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention