BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC IMPLANT

    MDR report key: 1915381 · Received November 3, 2010

    Report

    Report Number
    1030489-2010-01425
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    June 1, 2008
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADD'L DEVICE INFO. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS, IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    BROKEN SCREWS WERE REPORTED BY A PT. NO SPECIFIC INFO COULD BE PROVIDED REGARDING IMPLANT OR EXPLANT OPERATIVE PROCEDURES OR DATES. THE PT CLAIMS TO HAVE THE SCREWS IN HIS POSSESSION. NO DETAILS COULD BE OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR