BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6705077 · Received July 12, 2017

    Report

    Report Number
    1030489-2017-01741
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 13, 2017
    Report Date
    June 13, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9790213, 510K #K042922 AND UDI #(B)(4) WAS CLEARED IN THE UNITED STATES. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL FUSION. POST OP, THE SCREWS WERE FOUND TO BE LOOSENED. IN CAUDAL SIDE, SCREWS CAME OFF FROM VERTEBRAL BODIES. THE SCREW WAS ALSO INSERTED INTO BONE GRAFT, SO THAT BONE GRAFT ITSELF WAS BACK-OUT. THEREFORE, DYSPHAGIA WAS DEVELOPED IN THE PATIENT. THE PATIENT UNDERWENT A REVISION SURGERY FOR THE REMOVAL OF THE SCREWS. IT WAS OBSERVED IN THE REVISION SURGERY THAT ALL 4 SCREWS BACKED OUT SO ALL 4 SCREWS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486287 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA H5309584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R