BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2191453 · Received August 4, 2011

    Report

    Report Number
    1030489-2011-01001
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8392037, 510K # K031967WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CLOSE THE PATIENT AT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION SYSTEM AT L4-L5-S1 (ONLY RIGHT SIDE)-ILIAC, LOOSENING OF THE CONNECTION BETWEEN A SCREW AND THE CONNECTER OF RIGHT ILIAC WAS CONFIRMED BY THE IMAGES. THE INCISION WAS RE-OPENED TO REPLACE THE LARGE SIZED CONNECTER WITH AN MEDIUM SIZED CONNECTER. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. THE EVENT DID NOT HAVE ANY IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK NA 0119399W

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention SCREWS