BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC IMPLANT

    MDR report key: 1895369 · Received November 3, 2010

    Report

    Report Number
    1030489-2010-01422
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 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
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADDITIONAL 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

    THE PT'S ATTORNEY ALLEGES THAT ON AN UNDISCLOSED DATE THE PT UNDERWENT SURGERY THAT INCLUDED A POSTERIOR LUMBAR FUSION (PLIF) FROM "L3-S1 WITH DECOMPRESSION, LAMINECTOMY, AND MEDIAL FACETECTOMY AND FORAMINOTOMIES WAS PERFORMED. PEDICLE SCREWS WERE PLACED AT L3, L5, AND S1." IT IS ALLEGED THAT SOME TIME FOLLOWING THE SURGERY "TWO DEFECTIVE TITANIUM SCREWS PLACED AT THE S1 LEVEL BROKE AND SUBSEQUENTLY HAD TO BE SURGICALLY REMOVED." NO EXPLANT DATE IS GIVEN. IT IS ALSO ALLEGED THAT AS A RESULT OF THE "INCIDENT", THE PT SUSTAINED BODILY INJURIES, WHICH WERE NOT DESCRIBED. NO OTHER DETAILS WERE MENTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization