BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCM CERVICAL DISC SYSTEM

    MDR report key: 4792539 · Received May 12, 2015

    Report

    Report Number
    2031966-2015-00023
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 14, 2015
    Report Date
    May 11, 2015
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P100012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RADIOGRAPHS CONFIRMING THE LEVEL OR THE EVENT WERE NOT RECEIVED. IT WAS REPORTED THAT THE PATIENT'S ANATOMICAL CHARACTERISTICS (LACK OF BONE ON THE LEADING EDGE OF THE VERTEBRAL BODY) DID NOT PROVIDE SUFFICIENT SUPPORT FOR THE PROSTHETIC WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE DEVICE HAS NOT YET BEEN RETURNED AND NO FURTHER INVESTIGATION CAN BE COMPLETED AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT AND SIMILAR EVENTS NOTES NO MATERIAL NON-CONFORMANCE'S OR MANUFACTURING ERRORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS FAILURE MODE. NO ROOT CAUSE HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A (B)(6) MALE REPORTEDLY UNDERWENT A SINGLE LEVEL CERVICAL ARTHROPLASTY. AT THE 6 WEEK POST-OPERATIVE VISIT, IT WAS NOTED THAT THE PROSTHETIC DEVICE HAD MIGRATED ANTERIORLY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015. PATIENT CONDITION AND STATUS OF HEALTH PRIOR TO EVENT IS UNKNOWN. PATIENT ACTIVITY LEVEL, BONE QUALITY AND COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308497 PCM CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO NUVASIVE, INC. 7680365 SV8317

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR