BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3120229 · Received May 20, 2013

    Report

    Report Number
    1030489-2013-01761
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K970806
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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 ORIGINALLY UNDERWENT A C5-C6 DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT POST-OPERATIVE RADIOGRAPHIC IMAGING CONFIRMED A FRACTURED 4.0X15MM INTERBODY SCREW. THE BROKEN SCREW ALONG WITH THE PLATE AND OTHER SCREWS WERE REMOVED APPROXIMATELY 12.25 YEARS POST-OPERATIVELY. NO FURTHER INFORMATION COULD BE OBTAINED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222955 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention CERVICAL PLATE, SCREWS