BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2652886 · Received July 12, 2012

    Report

    Report Number
    1030489-2012-01124
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR USE BY USER FACILITY/IMPORTER (DEVICES ONLY). (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# G876H713, LOT H10E2052, EXPIRATION DATE 2018/06/07;, LOT H10E2053, EXPIRATION DATE 2018/06/17; LOT H10H0234, EXPIRATION DATE 2018/08/20; PART# G876H853, LOT H09M8520, EXPIRATION DATE 2017/12/21. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 876-713, 876-853, 510K # K970806 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H10E2052 IS (B)(4) 2010; THE MANUFACTURE DATE FOR LOT H10E2053 IS (B)(4) 2010; THE MANUFACTURE DATE FOR LOT H10H0234 IS (B)(4) 2010, MANUFACTURE DATE FOR LOT H09M8520 IS (B)(4) 2009: NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO "DEVICES WERE BACKED OUT" AND CAUSING THE PATIENT DYSPHAGIA. THE PLATE AND SCREWS WERE EXPLANTED SINCE THE BONE FUSION WAS ALMOST COMPLETE. 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 KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA

    Patients

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