BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 7034426 · Received November 15, 2017

    Report

    Report Number
    1030489-2017-02342
    Event Type
    Injury
    Date Received
    November 15, 2017
    Report Date
    November 15, 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 # 9790215, 510K #K042922 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.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: CERVICAL SPONDYLOTIC AMYOTROPHY TYPE OF PROCEDURE OR TECHNIQUE USED: C3-6: ANTERIOR FUSION IT WAS REPORTED THAT ON POST-OP, THE SCREW OF CAUDAL SIDE WAS BACKED OUT TWO WEEKS AFTER THE SURGERY. REVISION SURGERY OCCURRED WHERE THE SCREW WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812128 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA H5243240

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention