BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1914033 · Received December 3, 2010

    Report

    Report Number
    1030489-2010-01533
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INC
    Product Code
    KWQ
    PMA / PMN Number
    K042922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE ANTERIOR CERVICAL PLATE BROKE DURING IMPLANTATION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1