BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA TITANIUM 4.5 BLOCKER

    MDR report key: 2152302 · Received June 23, 2011

    Report

    Report Number
    9617544-2011-00213
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 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 EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THIS CASE TOOK PLACE ON (B)(6) 2011 AT (B)(6) HOSPITAL. SCHEDULED AS A T2-S2 SCOLIOSIS CORRECTION. LUQUE WIRES FROM T2-T10 AND XIA 4.5 SCREWS FROM T12-S2; AT S2 USED THE S2AI TECHNIQUE. FROM THE CONVERSATION WITH DR. (B)(6), THE PERFORMING SURGERY, HE BELIEVED THE RODS SLIPPED OUT OF THE S2 SCREWS. HE BELIEVED THE RODS MIGRATED SUPERIORLY. LOOKING CLOSER AT THE X-RAYS IT APPEARS TO ME THAT AT THE LEVELS OF L2-L3 THE BLOCKERS ARE NOT IN THE TULIP HEADS AND THERE ARE OTHERS THAT LOOK LIKE THEY ARE BACKING OUT. AS I RECALL THE DAY OF THE CASE I REMEMBER TORQURING DOWN AT EACH LEVEL WE USED THE T-HANDLE AND ANTI TORQUE FOR EACH SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 BLOCKER IMPLANT NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR