BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3120736 · Received May 20, 2013

    Report

    Report Number
    1030489-2013-01772
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K970806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL ACDF PROCEDURE AT C6-7 USING A CERVICAL PLATE SYSTEM AND RECENT POST-OP "RADIOGRAPHIC IMAGES INDICATED FRACTURED SCREWS FROM SURGERY EIGHT AND A HALF YEARS AGO". A REVISION SURGERY WAS PERFORMED ON THE PATIENT AND, ACCORDING TO THE REPORT, "SCREWS AND PLATE WERE REMOVED DURING THE REVISION SURGERY INVOLVING C6-7". NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221855 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention CERVICAL PLATE, SCREWS