BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1519366 · Received October 30, 2009

    Report

    Report Number
    1030489-2009-01017
    Event Type
    Injury
    Date Received
    October 30, 2009
    Report Date
    October 5, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9791323, 510K # K061274 WAS CLEARED IN THE UNITED STATES. THE EXPLANTED IMPLANT IS NOT RETURNED FOR EVALUATION. THE LATERAL CERVICAL FILM SHOWS ACDF AT C3-C4-C5. SCREW AT C5 HAS BACKED OUT APPROXIMATELY 50% OF THE LENGTH. PLATE/SCREW TRAJECTORY APPEARS WITHIN ACCEPTABLE RANGE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACDF AT C4-C6 USING ANTERIOR FIXATION PLATE AND SCREWS. THE SCREW AT LEFT C6 BACKED OUT POST OP. THE PATIENT COMPLAINED OF DYSPHAGIA. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY TWO WEEKS POST OP TO REMOVE THE WHOLE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWP MEDTRONIC SOFAMOR DANEK NA H08K9506

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention LOT# H08K9504| LOT# H08K9503| PLATE: CATALOG # G9790040| LOT# 0011787W| BONE SCREW: CATALOG # G9791323