BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C DIAM.4.0MM SELF DRILLING 10MM

    MDR report key: 3110546 · Received May 14, 2013

    Report

    Report Number
    3005525032-2013-00044
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVE
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT MADE AVAILABLE.

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE SCREW (1 ANCHOR C DIAM. 4.0MM SELF DRILLING 10MM) WAS NOT RETURNED FOR INVESTIGATION AS COMMUNICATED ON (B)(6) 2013. THIS DEVICE IS PART OF THE ANCHOR C PRODUCT BRAND. THE LOT NUMBER IS UNKNOWN AND NO MANUFACTURING RECORD CAN BE REVIEWED. FURTHERMORE NO VISUAL INSPECTION WAS CONDUCTED AS THE DEVICE WAS NOT RETURNED. PAST INVESTIGATIONS CONCLUDED THAT DISLODGMENT OF THE CLIP WAS PROBABLY DUE TO INCORRECT DRILLING OR SCREW INSERTION DIRECTION DUE TO CANTILEVER FORCES. SINCE THE ACTUAL DEVICE WAS NOT RETURNED A SIMILAR CONCLUSION CAN BE DRAWN. CONCLUSION: THE REPORTED EVENT OF LOCKING RING DETACHING FROM 1 ANCHOR C DIAM.4.0MM SELF DRILLING 10MM CAGE WAS CONFIRMED BY SALES REPRESENTATIVE. THE LOCKING RING WAS REPORTED AS COMING OFF DURING SCREW INSERTION; NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. HOWEVER THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A THOROUGH INVESTIGATION COULD NOT BE COMPLETED. THE EXACT CAUSE OF THE DETACHMENT WAS NOT DETERMINED AND A POTENTIAL ROOT CAUSE CANNOT BE PROPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "LOCKING RING COME OFF SELF DRILLIMG SCREW 10MM.10 MM SELF TAPPING WAS USED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "LOCKING RING COME OFF SELF DRILLIMG SCREW 10MM.10 MM SELF TAPPING WAS USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212812 ANCHOR C DIAM.4.0MM SELF DRILLING 10MM ANCHOR C DIAM.4.0MM SELF DRILLING 10MM OVE STRYKER SPINE-SWITZERLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR