BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE GRAFT WASHER

    MDR report key: 1961400 · Received January 14, 2011

    Report

    Report Number
    1030489-2011-00042
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K994122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE USING THE DEVICE. IN THE 15 MONTHS SINCE THE SURGERY, THE PATIENT HAS REPORTED EXPERIENCING SYMPTOMS THAT ARE AGGRAVATED BY DRIVING MORE THAN 30 MINUTES AT A TIME. THE PATIENT RECENTLY PRESENTED TO THE ER DUE TO PAINFUL BLADDER AND URINARY SYMPTOMS THAT WERE FOLLOWED BY PAINFUL BOWEL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE GRAFT WASHER APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other