BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 4092928 · Received September 16, 2014

    Report

    Report Number
    1030489-2014-03671
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MANUAL FUNCTIONAL REVIEW OF THE RETURNED CUTTER DID IDENTIFY SOME BINDING. VISUAL INSPECTION OF THE INDIVIDUAL INSTRUMENT COMPONENTS, GEAR AND PINION DID IDENTIFY WEAR. SEVERAL MEASUREMENTS WERE TAKEN FROM BOTH SIDES OF THE CUTTER AND THERE DID NOT APPEAR TO BE ANY OUT OF SPECIFICATION CONDITION THAT WOULD LEAD TO THE CUTTER NOT CUTTING PROPERLY. VISUALLY THERE IS SOME WEAR ON THE CUTTING SURFACES THAT COULD CAUSE EACH SIDE TO CUT DIFFERENTLY. CONCLUSION: AFTER VISUAL, DIMENSIONAL, AND FUNCTIONAL EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE FOR IMPLANT OF ARTIFICIAL CERVICAL DISC. WHILE PREPARING THE ENDPLATES, THE CUTTER INSTRUMENT WAS ONLY ABLE TO CUT THE SUPERIOR ENDPLATE. AFTER SEVERAL ATTEMPTS, A NEW CUTTER WAS OPENED AND USED WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572641 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA EM13H045

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR