BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS ROD

    MDR report key: 1840861 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00301
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 1, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNI
    PMA / PMN Number
    K032394
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    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 CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    SALES REP (B)(4) REPORTED THAT (B)(6) REPORTED TO HER THAT THE PATIENT CAME IN TO THE ER DUE TO PART OF THE ROD WAS STICKING OUT FROM HER BACK. ON 05/07/2010 ADD'L INFO GIVEN BY NURSE (B)(6), "RA PATIENT OPERATED FIRST TIME ON (B)(6) 2009 BY DOCTOR (B)(6), POSTERIOR FUSION WITH FIXATION OCCIPUT TO TH2, OCCIPUTPLATE (SYNTHES) AND SCREWS (OASYS, STRYKER). REOPERATION ((B)(6) 2010) DUE TO HER VISIT AT THE ER. REOPERATED BY PROF (B)(6) AND (B)(6). INDICATION IS LOOSENING OF ROD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS ROD IMPLANT MNI STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK