BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2981561 · Received February 27, 2013

    Report

    Report Number
    1030489-2013-00642
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    December 2, 2010
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K081038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A C5-C6 AND C6-C7 BI-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH CORTICAL RING ALLOGRAFTS AND A CERVICAL PLATE SYSTEM. IT WAS REPORTED THAT APPROXIMATELY 35 MONTHS POSTOPERATIVELY, THE PATIENT COMPLAINED OF NECK PAIN. TREATMENT INCLUDED SKELAXIN 800MG. APPROXIMATELY 38 MONTHS POSTOPERATIVELY, THE PATIENT HAD A CT SCAN WHICH SHOWED PSEUDOARTHROSIS AT C5-C6. TREATMENT INCLUDED SKELAXIN, IBUPROFEN, CELEBREX, TYLENOL AND FLEXERIL. APPROXIMATELY 39 MONTHS POSTOPERATIVELY, A THIN CT WAS ORDERED. APPROXIMATELY 44 MONTHS POSTOPERATIVELY, THE PATIENT HAD A C5-C6 POSTERIOR FUSION AND POSTEROLATERAL MASS SCREWS, RODS, AND BMP. ADDITIONAL TREATMENT INCLUDED NORCO 10 QUANTITY 60 AND A MEDROL DOSE PAK. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84379 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORTICAL RING ALLOGRFTS, 4X13 SELF DRILL VA SCREWS