BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3630802 · Received February 17, 2014

    Report

    Report Number
    1030489-2014-00493
    Event Type
    Injury
    Date Received
    February 17, 2014
    Date of Event
    May 21, 2010
    Report Date
    February 28, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 6955722, 6955720, 6955724, AND 6900240 WITH 510K # K043020 AND K123906 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G6945722 / LOT: UNKNOWN (X4) PART: G6945720 / LOT: UNKNOWN PART: G6945724 / LOT: UNKNOWN PART: G6900240 / LOT: UNKNOWN (X2) ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SPINAL SURGERY AT C2-6. SOMETIME POST-OP IT WAS REPORTED THAT THE PATIENT HAD C5 PALSY. THE PATIENT WAS SENT TO PHYSICAL THERAPY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100162 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention RODS, SCREWS, SETSCREWS