BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3191367 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02549
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. IMPLANTED IN 2004. MONTH AND DAY UNKNOWN. (B)(6). (B)(4). PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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 UNDERWENT A SPINAL FUSION USING A 95MM PLATE WITH PEDICLE SCREWS FROM C3-T1. THE PATIENT CLAIMS "ONE OF THE SCREWS WOBBLED AND FRACTURED THE C2 VERTEBRA SEVERAL MONTHS LATER" AND STATED THAT "LIFE IS NOTHING" AND THE PATIENT "WAS A CODE BLUE THE NEXT DAY". PATIENT CLAIMS "THE RODS ARE DIFFERENT LENGTHS AND THE HOSPITAL REFUSES TO GIVE MEDICAL RECORDS". NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289940 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other