BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C DIAM.3.5MM SELF DRILLING 10MM

    MDR report key: 3200966 · Received July 2, 2013

    Report

    Report Number
    3005525032-2013-00062
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVE
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE RETURNED SCREW DOES NOT PRESENT ANY ABNORMALITY THAT CAN EXPLAIN THE REPORTED EVENT. THE LOCKING RING SEEMS TO CONFORM AND PROPERLY LOCK IN PLACE. FUNCTIONAL INSPECTION: NO FUNCTIONAL INSPECTION WAS MADE. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: LOCKING OF ANCHOR C DIAM.3.5MM SELF DRILLING 10MM, WAS REPORTED NOT POSSIBLE DURING SURGERY. THE SCREW WAS RETURNED, INSPECTED AND NO ANOMALY WAS OBSERVED. ALSO NO ANOMALY THAT COULD BE ASSOCIATED WITH THE EVENT WAS REPORTED DURING THE MANUFACTURING OF THIS BATCH. THE PRESENT EVENT DESCRIBES AN IMPOSSIBILITY TO LOCK THE SCREW WHICH CAN BE THE CONSEQUENCE OF AN INCORRECT INSERTION PATH, SIMILAR TO THE EVENTS WHERE THE SCREW CANNOT BE INTRODUCED FULLY. THE CAUSE OF THE REPORTED EVENT CANNOT BE CLEARLY IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN ATTEMPTING TO INSERT THE 3.5X10 SELF DRILLING SCREW INTO THE PLATE IT WOULD NOT LOCK INTO PLACE. THE SCREW WAS REMOVED AND REPLACED WITH A 4.0X8 SELF TAPPING SCREW WHICH SEATED CORRECTLY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN ATTEMPTING TO INSERT THE 3.5X10 SELF DRILLING SCREW INTO THE PLATE IT WOULD NOT LOCK INTO PLACE. THE SCREW WAS REMOVED AND REPLACED WITH A 4.0X8 SELF TAPPING SCREW WHICH SEATED CORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303108 ANCHOR C DIAM.3.5MM SELF DRILLING 10MM IMPLANT OVE STRYKER SPINE-SWITZERLAND M8G

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR