BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA BLOCKER

    MDR report key: 2102284 · Received April 12, 2011

    Report

    Report Number
    9617544-2011-00167
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 14, 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
    GM
    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 EVAL.

    Description of Event or Problem · 1

    DR (B)(6), POSITION UNK, REPORTED VIA OUR SALES REP (B)(4) THAT DURING THE FINAL TURN ON OF THE BLOCKER, THE 12NM TORQUE OVERRAN AND DEVICE CRACKED. FURTHER, IT WAS REPORTED THAT SURGERY WAS CONTINUED WITH ALTERNATIVE AND FINISHED WITH 5 MINUTES DELAY AND WITH DESIRED RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK