BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 8987961 · Received September 11, 2019

    Report

    Report Number
    1030489-2019-01008
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 11, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 #: 9791225, 510K #: K061274 AND UDI #: (B)(4) 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC RADICULOPATHY; AND UNDERWENT ANTERIOR FIXATION AT C5-C6. THE PATIENT WAS IN HIS FORTIES HIS BONE QUALITY WAS HARD. INTRA-OP, THE SOCKET OF THE SCREW STRIPPED DURING FINAL TIGHTENING WITH THE SCREWDRIVER. THE SURGEON CONTINUED TO PERFORM LOCKING AND THE OPERATION WAS COMPLETED. TAPPING WAS NOT PERFORMED. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785505 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR SCREWDRIVER