BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 30 MM

    MDR report key: 3041449 · Received April 8, 2013

    Report

    Report Number
    3005525032-2013-00031
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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

    THE SCREW WAS NOT RETURNED FOR INSPECTION. AN INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. NO OTHER ADDITIONAL INFORMATION WAS MADE AVAILABLE AND FURTHER INVESTIGATION CANNOT BE PERFORMED. NO PRODUCT RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ... "DURING THE PROCEDURE, WHILE THE SURGEON WAS SCREWING THE BLOCKER, THE TULIP IS BROKEN. THE BROKEN SCREW HAS BEEN REMOVED AND REPLACED WITH A NEW ONE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "DURING THE PROCEDURE, WHILE THE SURGEON WAS SCREWING THE BLOCKER, THE TULIP IS BROKEN. THE BROKEN SCREW HAS BEEN REMOVED AND REPLACED WITH A NEW ONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143808 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 30 MM IMPLANT MNH STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1