BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3630812 · Received February 17, 2014

    Report

    Report Number
    1030489-2014-00489
    Event Type
    Injury
    Date Received
    February 17, 2014
    Date of Event
    March 10, 2009
    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 6955834, 6955830, 6955832, 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: G6945834 / LOT: UNKNOWN PART: G6945830 / LOT: UNKNOWN (X3) PART: G6945832 / LOT: UNKNOWN (X2) 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

    THE SUSPECT DEVICE WAS NOT IDENTIFIED; THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE: G6900240, W08E0195; G6945830, W07B3602; G6945830, W07D4373; G6945832, W07E5473; G6945834, W07E5476; G6950305, W08D1884; G7002527, W08C1176. (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. 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 SPINAL CERVICAL PROCEDURE AT C3-C7 WITH BILATERAL LAMINECTOMY, DOME OSTEOTOMY AND FORAMINOTOMY. APPROXIMATELY 3 WEEKS POST-OP THE PATIENT UNDERWENT A DEBRIDEMENT SURGERY AND IRRIGATION DUE TO INCISION SITE INFECTION, PYREXIA, SWELLING AND TENDERNESS, LEVOFLOXACIN HYDRATE WAS ADMINISTERED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 3 MONTHS POST-OP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99945 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention RODS, SCREWS, CROSSLINK, SETSCREWS