BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2012-02439

    MDR report key: 2800367 · Received October 22, 2012

    Report

    Report Number
    2520274-2012-02439
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 26, 2012
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE WAS USED FOR TREATMENT. CONSTRUCT HAS VARIABLE COMPONENTS, WITHOUT A PART NUMBER THIS DEVICE CAN NOT BE IDENTIFIED. REPORT ORIGINALLY RECEIVED (B)(4) 2012; FURTHER EVALUATION REVEALED 19 ADDITIONAL DEVICES WITHIN THE REPORTED EVENT WHICH WERE IDENTIFIED ON (B)(6) 2012. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS DEVICE WAS NOT RETURNED AND LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT UNDERWENT A REVISION PROCEDURE FOR REMOVAL OF L3 - L5 USS RODS AND SCREWS ON (B)(6) 2006. L1 AND L2 LAMINECTOMIES WERE PERFORMED. A PEDICLE SUBTRACTION OSTEOTOMY WAS PERFORMED AT L2 WITH DECANCELLATION OF THE L2 VERTEBRAL BODY. PEDICLE SCREWS WERE INSERTED BETWEEN T11 AND L5 IN THE RIGHT AND T11 AND L4 ON THE LEFT. THE OSTEOTOMY WAS CLOSED WITH 25 DEGREES OF CORRECTION. THIS IS THE 8TH OF 20 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KWQ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BONE GRAFT