BEUDAMED
    FDA Adverse Event Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3042777 · Received April 9, 2013

    Report

    Report Number
    1030489-2013-00951
    Date Received
    April 9, 2013
    Date of Event
    December 23, 2011
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K970806
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 STUDY PATIENT UNDERWENT A C5-C6 AND C6-C7 BI-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE WITH CORTICAL RING ALLOGRAFTS AND AN ANTERIOR CERVICAL PLATE SYSTEM. APPROXIMATELY 57 MONTHS POSTOPERATIVELY, THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT (MVA) AND REQUIRED EMERGENCY SPINAL CORD DECOMPRESSION AT C4-C5. THE PATIENT HAD PRIOR FUSION SURGERY AT C5-C7: AND THE PLATE WAS REMOVED TO ACCESS C4-C5. THE C5-C7 PLATE WAS REMOVED. HOSPITALIZATION WAS REQUIRED. THE TOP AND BOTTOM LEFT SCREWS WERE FOUND TO BE BROKEN. SOLID BRIDGING OF THE FUSION WAS FOUND INTRAOPERATIVELY. MYELOPATHY AND RADICULOPATHY WERE ALSO PRESENT. UPON FURTHER REVIEW OF THE CAT SCAN TAKEN PREVIOUSLY, THE REMAINDER OF THE BROKEN SCREWS WAS LEFT WITHIN THE BONE. APPROXIMATELY 64 MONTHS POSTOPERATIVELY, IT WAS NOTED THAT THE SPINAL CORD WAS DECOMPRESSED AND THE FUSION WAS FULLY BRIDGED. IT WAS ALSO NOTED THAT THE GROSS ANATOMICAL DEFECT WAS CORRECTED. HOWEVER, SYMPTOMS PERSISTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147661 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R ANTERIOR CERVICAL PLATE, CORTICAL RING ALLOGRAFTS