BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5629655 · Received May 4, 2016

    Report

    Report Number
    1030489-2016-01289
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 5, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    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 # 9790040, 510K # (B)(4)) WAS CLEARED IN THE UNITED STATES. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: "CSM", THE ENUCLEATION OF VERTEBRAL BODY OF C5 C4-C6: FIXATION PROCEDURE: CERVICAL ANTERIOR FUSION IT WAS REPORTED THAT INTRA-OP, THE LOCKING RING OF THE PLATE DID NOT RETRACT WHEN THE SCREW WAS INSERTED, ALTHOUGH NO PROBLEM WAS FOUND WITH THE DEPTH OF THE SCREW. WHEN THE SURGEON WAS USING A DTS DRILL GUIDE AT THE SURGERY THE SURGEON FOUND IT DIFFICULT TO HOLD THE IMPLANT. IT SEEMED TO BE LOOSENED A LITTLE. SURGEON COMMENTED THAT THE RING OF THE PLATE DID NOT COME OUT PROBABLY DUE TO TOO MUCH FORCE APPLIED BY THE NURSE TO THE PLATE DURING PRACTICE WHICH MIGHT HAVE DEFORMED IT. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE REMAINS IMPLANTED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287008 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0317221W

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS