BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA LP TRANSVERSE HK R

    MDR report key: 1740384 · Received June 17, 2010

    Report

    Report Number
    9617544-2010-00253
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    BEFORE THE SURGERY (BEFORE CLEANING) AT THE HOSPITAL, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL ON THE THREADS OF SOME HOOKS. THEY CLEANED THESE AND THE FOREIGN MATERIALS WERE GONE BUT ONE HOOK STILL HAD THE FOREIGN MATERIAL ON THE THREAD. OUR LOANER DEPARTMENT INSPECTS ALL THE IMPLANTS BEFORE SHIPPING THEM TO OUR CUSTOMER. THERE WAS NO FOREIGN MATERIAL FOUND ON THE THREAD WHEN WE INSPECTED IT BEFORE SHIPPING. <INTERNAL COMMENT> THE HOOKS ARE PUT ON THE RUBBER PAD IN THE TRAY AND WE ASSUME THAT THE PART OF THE RUBBER PAD SHEDDED BY THE THREADS OF THE HOOKS AND THOSE SHEDDINGS STICKED TO THE...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP TRANSVERSE HK R IMPLANT NKB STRYKER SPINE BORDEAUX NA A90314

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK