BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP POLYAXIAL SCREW 5.5 X 45MM

    MDR report key: 1041125 · Received May 6, 2008

    Report

    Report Number
    9617544-2008-00038
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    July 1, 2007
    Report Date
    April 17, 2008
    Manufacturer
    STRYKER SPINE BORDEUX
    Product Code
    HWC
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS LIMITED INFO AT THIS TIME. REFERENCE NUMBERS 03821640 XIA LP POLYAXIAL SCREW 6.5 X 40 MM & 03821645 XIA POLYAXIAL SCREW 6.5 X 45 MM ARE ALSO ASSOCIATED WITH THE EVENT, BUT IT IS UNK WHICH, IF ANY, OF THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUPPLIED ON A SUPPLEMENTAL.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LEGAL CLAIM "THE CLAIMANT ALLEGES XIA SCREW FAILURE, ONE OF THE SACRAL TRANSPEDICULAR SCREWS WAS LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 5.5 X 45MM IMPLANT HWC STRYKER SPINE BORDEUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention