BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2895515 · Received January 3, 2013

    Report

    Report Number
    1030489-2013-00014
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE (CATALOG # 9790045, 510K # K061274) WAS CLEARED IN THE UNITED STATES. EXPLANT DATE IS UNKNOWN. (B)(4). (MIGRATION OF DEVICE OR DEVICE COMPONENT). 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 A PROCEDURE AT C5-C7 USING A CERVICAL PLATE AND SCREWS. SOMETIME POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE RIGHT C7 SCREW BACKING OUT. DURING THE SCREW REMOVAL, IT WAS NOTICED THAT THE RIGHT LOCKING RING WAS MISSING FROM THE CONSTRUCT BUT COULD NOT BE FOUND IN THE PATIENT. THE REVISION SURGERY WAS COMPLETED WITHOUT REPLACING C7 SCREWS DUE TO THE MISSING LOCKING RING ON THE PLATE. THE PATIENT REPORTEDLY "HAD DYSPHAGIA DUE TO SCREW BACK OUT." NO FURTHER INCIDENT WAS REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0007816W

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR SCREWS