BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 60 MM

    MDR report key: 1180096 · Received September 29, 2008

    Report

    Report Number
    9617544-2008-00107
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 1, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODES WILL BE DETERMINED AND REPORTED ON A SUPPLEMENTAL FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    DR REPORTED VIA OUR SALES REP, THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO THE FACT THAT THE HEAD OF THE POLYAXIAL SCREW BECAME LOOSE. ACCORDING TO THE SURGEON, THE PATIENT WAS BEDRIDDEN. THEREFORE, HE HAS THE OPINION THAT THE PATIENT INFO REGARDING HEIGHT, WEIGHT ETC. ARE NOT RELEVANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 60 MM IMPLANT KWP STRYKER SPINE BORDEAUX NA A80376

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other