BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3033030 · Received April 3, 2013

    Report

    Report Number
    1030489-2013-00927
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2011
    Report Date
    March 12, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). LOCATION: HOSPITAL. NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT SURGERY ON FOR ANTERIOR CERVICAL DISCECTOMY FUSION AND DECOMPRESSION TO TREAT NECK PAIN AND LEFT ARM NUMBNESS. A TITANIUM ANTERIOR CERVICAL PLATE WAS IMPLANTED DURING THE PROCEDURE. ALLEGEDLY, IMMEDIATELY AFTER THE SURGERY THE PATIENT BEGAN SHOWING SIGNS OF NEUROLOGICAL INJURIES RESULTING IN PARALYSIS OF BOTH UPPER EXTREMITIES. SIX DAYS POST-OP THE PATIENT UNDERWENT A CORRECTIVE SURGERY. ALLEGEDLY, THE PATIENT CONTINUED TO HAVE PARALYSIS OF BOTH UPPER EXTREMITIES. THE PATIENT REPORTEDLY HAS HAD PHYSICAL THERAPY WHICH WAS UNSUCCESSFUL AND IS COMPLETELY DEPENDENT WITH ALL ACTIVITIES. ALLEGEDLY, THE PATIENT RECEIVED A TRAUMATIC IMPRESSION UPON THE SPINAL CORD DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136168 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S