BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3222711 · Received July 12, 2013

    Report

    Report Number
    1030489-2013-03009
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K021461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN 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. 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 "APPROXIMATELY 7 WEEKS POSTOPERATIVELY, THE PATIENT REPORTED PAIN IN THE CERVICOTHORACIC AREA. THE PATIENT WAS TREATED WITH LODINE. BLOODWORK AND AN MRI WERE ORDERED. APPROXIMATELY 3 MONTHS POSTOPERATIVELY, THE PATIENT CONTINUED TO REPORT NECK PAIN. REVIEW OF THE MRI REVEALED NO ABNORMALITIES. THE PATIENT WAS TREATED WITH AN NSAID AND REFERRED TO A PHYSIATRIST FOR FURTHER EVALUATION/TREATMENT. AT THE 3 MONTH POSTOPERATIVE EVALUATION, THE PATIENT CONTINUED TO HAVE PAIN ESPECIALLY IN LEFT PARASPINAL AREA. THE PATIENT WAS GIVEN A REFERRAL TO A SPECIALIST. AT THE 6 MONTH POSTOPERATIVE EVALUATION, THE PATIENT CONTINUED TO PRESENT WITH NECK PAIN. THE PATIENT WAS TREATED WITH RELAFAN AND A BONE SCAN WAS ORDERED. AT THE 12 MONTH POSTOPERATIVE EVALUATION, THE PATIENT CONTINUED TO REPORT INTERMITTENT SIGNIFICANT NECK PAIN, PREDOMINANTLY MUSCULAR IN ORIGIN. HOME STRETCHING EXERCISES WERE RECOMMENDED. APPROXIMATELY 19 MONTHS POSTOPERATIVELY, THE PATIENT WAS EVALUATED FOR CONTINUED COMPLAINTS OF LEFT SIDED NECK PAIN, MOST LIKELY A TRAPEZIUM MUSCLE SPASM. AN EMG, NERVE CONDUCTION STUDY, BONE SCAN WITH SPECT IMAGES, AND MEDICATIONS WERE ORDERED. THE PATIENT WAS EVALUATED AGAIN ONE MONTH LATER FOR A COMPLAINT OF SEVERE NECK PAIN RADIATING INTO THE LEFT SHOULDER. AN MRI AND CT WERE ORDERED AND THE PATIENT WAS GIVEN AN ASPEN COLLAR AS TREATMENT. ONE WEEK LATER, THE PATIENT WAS PRESCRIBED A BONE GROWTH STIMULATOR AS TREATMENT FOR CONTINUED SEVERE NECK PAIN. APPROXIMATELY 24 MONTHS POSTOPERATIVELY, THE PATIENT UNDERWENT A POSTERIOR C5-C6 LATERAL MASS SCREWS AND RODS WITH C5-C6 INTERSPINOUS WIRING AND ALLOGRAFT FUSION. PER THE OPERATION REPORT, THE PREOPERATIVE DIAGNOSIS WAS C5-C6 PSEUDOARTHROSIS. AT THE 24 MONTH STUDY EVALUATION, THE PATIENT HAD NO FURTHER COMPLAINTS OF NECK PAIN." NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323340 ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORNERSTONE BONE