BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 9173095 · Received October 9, 2019

    Report

    Report Number
    1030489-2019-01137
    Event Type
    Injury
    Date Received
    October 9, 2019
    Report Date
    October 9, 2019
    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 # 9791325, 510K # K061274 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR FIXATION AT C3-C7. ON AN UNKNOWN DATE, POST-OP, THE SCREW AT C3 BACKED OUT. THE SCREW HEAD HAD COME OUT A LITTLE FROM THE PLATE. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BACKED-OUT SCREW WAS REMOVED AND WAS REPLACED WITH A SCREW OF 4.0 MM × 19 MM. IT WAS CONFIRMED THAT THE NEWLY INSERTED SCREW WAS FIRMLY LOCKED NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967700 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention