BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4128691 · Received September 30, 2014

    Report

    Report Number
    1030489-2014-03755
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9790213 AND 510K # K042922 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION AT C3-C6 FOR C4/5 CSM ON AN UNSPECIFIED DATE. SEVERAL DAYS AFTER THE SURGERY, BOTH SCREWS INSERTED AT C3 WERE OBSERVED AS BEING BACKED OUT FOR APPROX. TWO-THIRDS OF LENGTH. IT WAS UNKNOWN WHETHER ANY ACCOMPANYING SYMPTOMS WERE NOTED. A REVISION SURGERY WAS PERFORMED TO REPLACE SCREWS AND PLATE. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608524 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H13J1674 (X2)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CERVICAL PLATE, SCREWS