BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 35

    MDR report key: 1884968 · Received October 22, 2010

    Report

    Report Number
    9617544-2010-00429
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. MULTIPLE SCREWS ARE REFERENCED IN THIS COMPLAINT FOR SCREW BACK OUT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6)2010: THE PRIMARY SURGERY (POSTERIOR FUSION) WAS PERFORMED FOR L2 FRACTURE. (SCREWS WERE PLACED ON TH12, L1, L3, L4, AND A CONNECTOR ON L2.) ON (B)(6)2010: THE SURGEON CONFIRMED THAT THE SCREWS AT L3 WERE BACKED OUT. (IT APPEARS THE SCREWS AT L4 AS WELL BACKED OUT BUT DIFFICULT TO CONFIRM BY X-RAY.) THE SURGEON CALLED THE SALES REP. AND INFORMED HIM THAT THE PATIENT WHO HAD THE PRIMARY SURGERY ON (B)(6) USING XIA FOR L2 FRACTURE WILL HAVE REVISION SURGERY DUE TO THE SCREW'S BACK-OUT. (HOWEVER THIS WAS WRONG INFORMATION. THE PATIENT TO BE REVISED ACTUALLY HAD THE PRIMARY SURGEON ON (B)(6)USING XIA4.5, NOT XIA) SINCE THERE WAS ANOTHER PATIENT WHO HAD PRIMARY SURGERY ON (B)(6) FOR L2...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 35 IMPLANT KWQ STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other