BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN® CERVICAL DISC SYSTEM

    MDR report key: 2590216 · Received May 29, 2012

    Report

    Report Number
    1030489-2012-00718
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    February 13, 2012
    Report Date
    May 2, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHUNG, SANG-BONG; MURADOV, J; LEE, SUN-HO; EOH, WHAN; KIM, EUN-SANG. UNCOVERTEBRAL HYPERTROPHY IS A SIGNIFICANT RISK FACTOR FOR THE OCCURRENCE OF HETEROTOPIC OSSIFICATION AFTER CERVICAL DISC REPLACEMENT: SURVIVORSHIP ANALYSIS OF BRYAN DISC FOR SINGLE-LEVEL CERVICAL ARTHROPLASTY. IN ACTA NEUROCHIR (THE EUROPEAN JOURNAL OF NEUROSURGERY) 2012; DOI 10.1007/S00701-012-1309-1. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED; THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) IN A PUBLICATION ENTITLED "UNCOVERTEBRAL HYPERTROPHY IS A SIGNIFICANT RISK FACTOR FOR THE OCCURRENCE OF HETEROTOPIC OSSIFICATION AFTER CERVICAL DISC REPLACEMENT: SURVIVORSHIP ANALYSIS OF BRYAN DISC FOR SINGLE-LEVEL CERVICAL ARTHROPLASTY" IN ACTA NEUROCHIR (THE EUROPEAN JOURNAL OF NEUROSURGERY) 2012, THAT THE PATIENTS UNDERWENT A SPINAL PROCEDURE USING A INTERVERTEBRAL DISC PROSTHESIS. THE STUDY WAS CONDUCTED TO INVESTIGATE THE INCIDENCE OF HETEROTOPIC OSSIFICATION (HO) IN THE CERVICAL ARTHROPLASTY GROUP AND TO IDENTIFY ASSOCIATIONS BETWEEN PREOPERATIVE FACTORS AND THE DEVELOPMENT OF HO WAS CONDUCTED. A SINGLE-LEVEL CERVICAL ARTHROPLASTY WITH THE PROSTHESIS BETWEEN WAS COMPLETED IN TWENTY-NINE PATIENTS BETWEEN (B)(6) 2005 AND (B)(6) 2007. OF THOSE TWENTY-NINE, NINETEEN PATIENTS WERE ANALYZED FOR THE STUDY (12 MEN,7 WOMEN). THE INTERVERTEBRAL DISC C4/5 WAS REPLACED IN ONE PATIENT, C5/6 IN NINE PATIENTS, AND C6/7 IN NINE PATIENTS. THE PATIENTS WITH PREOPERATIVE AXIAL NECK PAIN ARE SEVEN CASES AND THOSE WITH UVH ARE 11 CASES. IN THIS STUDY, SURVIVAL ANALYSIS DEMONSTRATED THAT 37% OF THE PATIENTS WHO UNDERGO DISC IMPLANTATION ARE EXPECTED TO HAVE ROM-AFFECTING HO WITHIN 24 MONTHS FOLLOWING ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRYAN® CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO MEDTRONIC SOFAMOR DANEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1