BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C DIAM.3.5MM SELF DRILLING 10MM

    MDR report key: 3972576 · Received August 1, 2014

    Report

    Report Number
    3005525032-2014-00085
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVE
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE LOCKING CLIP IS CONFIRMED TO BE FRACTURED UPON VISUAL INSPECTION. HALF OF THE RING IS STILL SEATED IN THE IMPLANT AND THE OTHER HALF HAS COMPLETELY DETACHED. CONCLUSION: THE ESTABLISHED CAUSE IS GENERAL USE ERROR.

    Description of Event or Problem · 1

    IT¿S REPORTED THAT THE SURGEON NOTICED A SMALL PIECE OF METAL AND CONCLUDED THAT THE SMALL PIECE OF METAL CAME FROM THE ANCHOR-C BONE SCREW. THE SURGEON PLACED IN A NEW ANCHOR-C BONE SCREW.

    Description of Event or Problem · 1

    IT铠REPORTED THAT THE SURGEON NOTICED A SMALL PIECE OF METAL AND CONCLUDED THAT THE SMALL PIECE OF METAL CAME FROM THE ANCHOR-C BONE SCREW. THE SURGEON PLACED IN A NEW ANCHOR-C BONE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451299 ANCHOR C DIAM.3.5MM SELF DRILLING 10MM IMPLANT-SCREW OVE STRYKER SPINE-SWITZERLAND 1

    Patients

    Seq Age Sex Outcome Treatment
    1