BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C DIAM.3.5MM SELF DRILLING 10MM

    MDR report key: 4836397 · Received June 10, 2015

    Report

    Report Number
    3005525032-2015-00068
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVE
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT CODE: FSZ. METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. CONCLUSION: THE ESTABLISHED CAUSE OF THE EVENT IS MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING RING ON SCREW BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING RING ON SCREW BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377032 ANCHOR C DIAM.3.5MM SELF DRILLING 10MM INTERVERTEBRAL BODY FUSION DEVICE OVE STRYKER SPINE-SWITZERLAND FSZ

    Patients

    Seq Age Sex Outcome Treatment
    1