BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2246842 · Received September 13, 2011

    Report

    Report Number
    1030489-2011-01152
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED; THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# G876H813, LOT H10A1763, EXPIRATION DATE 2018-01-22; LOT H10E2050, EXPIRATION DATE 2018-05-15; LOT H10F2436, EXPIRATION DATE 2018-01-18; LOT H10F3568, EXPIRATION DATE 2018-09-27. (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 876-813, 510K # K970806 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H10A1763 IS 01/22/2010; THE MANUFACTURE DATE FOR LOT H10E2050 IS 05/15/2010; THE MANUFACTURE DATE FOR LOT H10F2436 IS 01/18/2010; THE MANUFACTURE DATE FOR LOT H10F3568 IS 09/27/2010. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SUBTOTAL RESECTION OF C5-6 AND ANTERIOR FUSION AT C4-6. IT WAS REPORTED 7 DAYS POST-OP THAT THE SCREWS AT C7 WERE BACKING OUT. THE PATIENT UNDERWENT A REVISION SURGERY THE NEXT DAY, IN WHICH THE VERTEBRAL BODY REPLACEMENT WAS REMOVED AND FIBULA BONE WAS PLACED INSTEAD. THE PATIENT HAS BECOME FRAIL DUE TO RADIATION THERAPY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR PLATE