BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 40

    MDR report key: 3122968 · Received May 21, 2013

    Report

    Report Number
    0009617544-2013-00195
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K050461
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    RESULTS: NO X-RAYS/PHOTOS ARE AVAILABLE. PRODUCT WAS NOT RETURNED (DISPOSED). A ROOT CAUSE CANNOT BE DETERMINED (MULTI FACTORIAL). NOT ENOUGH INFORMATION WAS RECEIVED. FURTHER PATIENT INFORMATION COULD NOT BE OBTAINED, BUT IT SHOULD BE NOTED THAT OTHER FACTORS THAT CAN IMPACT THE SUCCESS OF UNION ARE OBESITY, SMOKING, AND PATIENT PATHOLOGIES. A LIST OF QUESTIONS WAS SENT OUT TO THE SALES REP FOR MORE INFORMATION ABOUT THE PATIENT (ADVERSE CONSEQUENCES, ACTIVITY LEVEL, INJURY, ECT...), BUT ANSWERS WERE MOSTLY UNKNOWN. CONCLUSION: THE EXACT CAUSE CANNOT BE DETERMINED WITHOUT A PRODUCT TO INSPECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT... "ON (B)(6) 2013, IT WAS FOUND THAT SER SCREW WAS LOOSE, STILL IN THE SCREW HEAD, AND ONE OF TWO CAGE IN BETWEEN L5 AND S WAS OUT OF THE POSITION. ON (B)(6) 2013 CAGE WAS REMOVED FROM THE PATIENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "ON (B)(6) 2013, IT WAS FOUND THAT SER SCREW WAS LOOSE, STILL IN THE SCREW HEAD, AND ONE OF TWO CAGE IN BETWEEN L5 AND S WAS OUT OF THE POSITION. ON 4/30/2013 CAGE WAS REMOVED FROM THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223583 XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 40 IMPLANT MNH STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R