BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP MONOAXIAL SCREW 5.5 X 40MM

    MDR report key: 1071416 · Received July 7, 2008

    Report

    Report Number
    9617544-2008-00056
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    March 14, 2008
    Report Date
    June 13, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE # 03821640 XIA LP POLYAXIAL SCREW 6.5 X 40MM WAS ALSO REFERENCED, IT IS UNK WHICH, IF ANY, OF THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PROD AND ADD'L INFO HAS BEEN REQUESTED, AND IF REC'D, WILL BE SUPPLIED ON A SUPPLEMENTAL.

    Description of Event or Problem · 1

    THE ORTHOPEDIC SURGERY REPORTED THAT AFTER L5-S1 SPONDYLODESIS A COUPLE OF MONTHS AGO, THAT FUSION DID NOT OCCUR IN THAT LEVEL. THE SURGEON REPORTED THAT THE SCREWS BROKE AND THE BLOCKERS CAME LOOSE. ACCORDING TO THE SURGEON, IT IS NOT CLEAR WHETHER THE SCREWS BROKE BECAUSE OF NO FUSION, OR NO FUSION OCCURRED BECAUSE THE SCREWS BROKE, OR IF THE BLOCKERS FINALLY WERE NOT TIGHTENED ENOUGH. THE SURGEON STATED THAT DURING REVISION SURGERY, THE SCREW THREADS HAD TO BE LEFT IN THE PT, BECAUSE IT WAS NOT POSSIBLE TO REMOVE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP MONOAXIAL SCREW 5.5 X 40MM IMPLANT KWP STRYKER SPINE BORDEAUX NA 04C720

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention