BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3193019 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02592
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 30, 2013
    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

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE: PART G6950315, LOT H12G1739; PART G6950315, LOT H12G1740; PART G6950315, LOT H13A4506; PART G6950315, LOT H13C2149; PART G6956412, LOT H11J3945; PART G6956412, LOT H13B2358; PART G6956414, LOT H13B2357; PART G6958934, LOT H10G3660; PART G6958934, LOT H11J5251; PART G6958934, LOT H12F2132; PART G7750087, LOT 0232754W; PART G7752536, LOT 0252850W. (B)(4). LOT H12G1739, MANF DATE: 8-AUG-12; LOT H12G1740, MANF DATE: 8-AUG-12; LOT H13A4506, MANF DATE: 25-JAN-13; LOT H13C2149, MANF DATE: 12-APR-13; LOT H11J3945, MANF DATE: 19-OCT-11; LOT H13B2358, MANF DATE: 27-MAR-13; LOT H13B2357, MANF DATE: 16-MAR-13; LOT H10G3660, MANF DATE: 30-JUL-10; LOT H11J5251, MANF DATE: 16-NOV-11; LOT H12F2132, MANF DATE: 2-JUL-12; LOT 0232754W, MANF DATE: 17-OCT-12; LOT 0252850W ,MANF DATE: 5-MAR-13. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT C5-T2 TO TREAT A C7 FRACTURE. SOMETIME POST-OP THE PATIENT UNDERWENT A REVISION SURGICAL PROCEDURE DUE TO POST-OP INFECTION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294657 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention