BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3044668 · Received April 9, 2013

    Report

    Report Number
    1030489-2013-00962
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    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 # 9790315, 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 ACDF PROCEDURE AT C4-C7 USING AN ANTERIOR CERVICAL PLATE AND A PEEK CAGE AT C5-C6. SOMETIME POST-OPERATIVELY IT WAS REPORTED THAT ONE OF THE SCREWS IN THE CONSTRUCT "BACKED OUT". BONE FUSION HAS NOT OCCURRED, HOWEVER, THE PATIENT IS ASYMPTOMATIC. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145688 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. NA H12J1242

    Patients

    Seq Age Sex Outcome Treatment
    1 ANTERIOR CERVICAL PLATE, PEEK CAGE