BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4271935 · Received November 23, 2014

    Report

    Report Number
    1030489-2014-04543
    Event Type
    Injury
    Date Received
    November 23, 2014
    Date of Event
    June 9, 2005
    Report Date
    January 17, 2009
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K021461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 876-713 / LOT: UNKNOWN (X4) PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICAL STUDY CONTROL PATIENT UNDERWENT AN ACDF PROCEDURE AT LEVEL C5-C6. THE FOLLOWING POST-OPERATIVE EVENT WAS REPORTED: POST OP VISIT DATE-2006/07/07 AE ONSET DATE: 2005/06/09; AE DESCRIPTION: PATIENT HAS SOME TINGLING IN HANDS AT TIMES BUT NO SENSORY DEFICIT. ON 6-9-05 INVESTIGATOR FEELS PT HAS A DELAYED NON-UNION BUT CLINICALLY IS DOING MODERATELY WELL. TREATMENT: NO; DESCRIPTION: RADIOGRAPHS SHOW A FIBROUS UNION WITH VERY LITTLE MOTION ON FLEXION/EXTENSION FILMS. OVERALL, THE PATIENT STATES DOING QUITE WELL EXCEPT FOR SOME INTERMITTENT NIGHT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759009 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Other CERVICAL PLATE SYSTEM, SCREWS