BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM

    MDR report key: 1082416 · Received July 18, 2008

    Report

    Report Number
    9617544-2008-00067
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A POSTEROLATERAL PEDICLE SCREW FIXATION WITH XIA 3 SET. ALL SCREWS WENT INTO PEDICLES WELL IN NORMAL FASHION. PT HAD DDD AT L5-S1 WITH GRADE 1/2 SPONDYLOLISTHESIS. WHEN PLACING RODS AND BLOCKERS, THE SURGEON NOTICED A SINGLE POPPING NOISE WHEN FINAL TIGHTENING BLOCKERS ON BOTH SACRAL 7.5MM DIAMETER SCREWS. THE SURGEON THEN NOTICED BOTH OF THE TULIPS POPPED OFF THE SHAFT OF THE SCREWS. HE THEN REMOVED ALL SCREWS AND REPLACED THEM WITH XIA II SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA A81568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other