BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP POLYAXIAL SCREW 6.5 X 45MM

    MDR report key: 1840882 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00306
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    December 1, 2008
    Report Date
    July 12, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REP THAT THE PATIENT HAD A REVISION OF XIA SCREWS. IT IS FURTHER REPORTED THAT THE ORIGINAL IMPLANTATION OCCURRED APPROX (B)(6) 2008 AND 2 SCREWS WERE INSERTED AT S1 ON BOTH THE LEFT AND RIGHT. IT IS FURTHER REPORTED THAT THE REVISION PROCEDURE OCCURRED APPROXIMATELY 6 MONTHS LATER ((B)(6) 2008). IT IS FURTHER REPORTED THAT ONE SCREW IS AVAILABLE, HOWEVER, APPROXIMATELY 1/3 OF THE SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 6.5 X 45MM IMPLANT KWQ STRYKER SPINE BORDEAUX NA A82368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK