BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASIS SPINAL SYSTEM

    MDR report key: 1772417 · Received July 23, 2010

    Report

    Report Number
    1030489-2010-00959
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 24, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SETSCREWS HAD LOOSENED AN UNK TIME POST-OP. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIS SPINAL SYSTEM SET SCREW KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention