BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C 6 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE

    MDR report key: 5984163 · Received September 28, 2016

    Report

    Report Number
    3005525032-2016-00119
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 29, 2016
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVE
    UDI-DI
    04546540679338
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED AS OF YET AND DESPITE OF MULTIPLE ATTEMPTS NO INFORMATION REGARDING THE RETURN OR THIS EVENT WAS PROVIDED. MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. THE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; SURGEON BROKE THE THREADED OBDURATE INSIDE OF A 6MM IMPLANT. NO ADVERSE CONSEQUENCES AND NO SURGICAL DELAY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; SURGEON BROKE THE THREADED OBDURATE INSIDE OF A 6MM IMPLANT. NO ADVERSE CONSEQUENCES AND NO SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637238 ANCHOR C 6 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE INTERVERTEBRAL BODY FUSION DEVICE OVE STRYKER SPINE-SWITZERLAND B44150 04546540679338

    Patients

    Seq Age Sex Outcome Treatment
    1