BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3630811 · Received February 17, 2014

    Report

    Report Number
    1030489-2014-00488
    Event Type
    Injury
    Date Received
    February 17, 2014
    Report Date
    February 28, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 6955720, 6955716, 6955714, 6955824, 6955826, 6900240 WITH 510K # K043020 AND K123906 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. D4. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G6945720 / LOT: UNKNOWN (X2) PART: G6945716 / LOT: UNKNOWN PART: G6945714 / LOT: UNKNOWN (X2) PART: G6945824 / LOT: UNKNOWN (X2) PART: G6945826 / 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, W07M1736; G6945714, W05K1581; G6945716, W07E5415; G6945720, W07E5425; G6945720, W07E5428; G6945824, W07D4370; G6945826, W07F3057; G6950305, W07J4419; G6950305, W07J4420; G6950305, W07J4421; G6950305, W08D1884; G7002526, W08C1175; G7002527, W06K0884. (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

    THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT C2-T2. APPROXIMATELY 2 MONTHS POST-OP THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE TO EXPLORE THE WOUND DUE TO A LESION. IT WAS THOUGHT THAT THE EVENT WAS DUE TO INVOLUNTARY MOVEMENT OF CEREBRAL PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100165 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS, SCREWS, SET SCREWS, CROSSLINK