BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA BLOCKER

    MDR report key: 1959682 · Received January 10, 2011

    Report

    Report Number
    9617544-2011-00001
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    September 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 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

    ON (B)(6) 2009, THE PRIMARY SURGERY WAS PERFORMED AT T10-L2 FOR OYL (OSTEOSIS OF YELLOW LIGAMENTS). ON (B)(6) 2010, THE SECOND SURGERY (OSTEOTOMY OF CEPHALIC HALF OF L3 VERTEBRA) WAS PERFORMED FOR OLD COMPRESSION FRACTURE WHICH DID NOT OBTAIN BONE FUSION. AND, T9-L5 WAS FIXATED WITH OIC CAGE (TITANIUM) WAS PLACED AT L3/L4 AND L4/L5. ON (B)(6) 2010, THE X-RAY SHOWED THAT THE BLOCKER AT THE RIGHT L5 LOOSENED. ON (B)(6) 2010, THE X-RAY SHOWED THAT THE BLOCKER AT THE RIGHT L5 DISASSEMBLED. ON (B)(6) 2010, THE X-RAY SHOWED THAT THE BLOCKER AT LEFT T9 DISASSEMBLED AND IT WAS FOUND AT POSTERIOR L1 WITHIN...

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR