BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4052016 · Received September 2, 2014

    Report

    Report Number
    1030489-2014-03604
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    April 23, 2007
    Report Date
    August 6, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 876-614 / LOT: UNKNOWN (X6) / 510K: K970806; PART: 976-145 / LOT: UNKNOWN / 510K: K021461. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICAL STUDY PATIENT RECEIVED A C5-C6 AND C6-C7 BI-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WITH CORTICAL RING ALLOGRAFTS AND A CERVICAL PLATE SYSTEM. AT THE 6 MONTH POSTOPERATIVE EVALUATION, THE PATIENT COMPLAINED OF INCREASING RESIDUAL CERVICALGIA AND INTERSCAPULAR PAIN WITH NO RADICULAR SYMPTOMS. PATIENT WAS PRESCRIBED NORCO AND REFERRED TO A PAIN MANAGEMENT SPECIALIST. POOR CONTROL OF PAIN WAS NOTED. AT THE 12 MONTH POSTOPERATIVE EVALUATION, IT WAS NOTED THAT A COMPARISON OF STUDY X-RAYS AT THIS VISIT SHOWED SOLID-APPEARING BONE GRAFT FUSION AT C6-C7 BUT LUCENCY AT SUPERIOR AND INFERIOR ASPECTS OF C5-C6 GRAFT. THERE WAS NO EVIDENCE OF HARDWARE FAILURE. ADDITIONAL TREATMENT INCLUDED 2 EMERGENCY ROOM VISITS FOR BACK AND NECK PAIN. THE PATIENT WAS PRESCRIBED PERCOCET, SOMA, NAPROSYN, VICODIN 5/500, AND FLEXERIL 10MG TID. THE PATIENT WILL BE PRESCRIBED NORCO 10/325MG (1 TO2 BY MOUTH TID) AND FLEXERIL 10MG TID AS NEEDED FOR SPASMS. THE PATIENT WAS ADVISED TO STOP SMOKING. AT THE 24 MONTH POSTOPERATIVELY EVALUATION, STUDY X-RAYS SHOWED ¿PERSISTENT LUCENCY AT C5-C6, C6-C7 AND HALOING AROUND SCREWS CONSISTENT WITH PSEUDOARTHROSIS¿. TREATMENT INCLUDED STUDY X-RAYS, FLEXERIL AND CONTINUATION OF PAIN MEDS: HYDROCODONE AND NORCO. AT THE 36 MONTH POSTOPERATIVE EVALUATION, NO TREATMENT WAS PROVIDED. AT THE 60-MONTH POSTOPERATIVE EVALUATION, THE PATIENT REPORTED RESIDUAL PARESTHESIA IN THE LEFT 3RD AND 4TH FINGERS AND PAIN IN THE SHOULDER (WITH OVERHEAD REACHING). ADDITIONAL TREATMENT INCLUDED METHADONE 30MG (BY MOUTH, BID) AND MEDICAL MARIJUANA. AT THE 84-MONTH POSTOPERATIVE EVALUATION, THE PATIENT COMPLAINED OF BILATERAL HAND NUMBNESS. THIS EVENT WAS PENDING AT THE 84-MONTH VISIT. NO ADDITIONAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534468 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention 45MM CERV PLATE, 4.0 X 14 SELF DRILL V.A. SCREWS