BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLIS STERILE CAGE

    MDR report key: 2831674 · Received November 9, 2012

    Report

    Report Number
    9617544-2012-00492
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    ODP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    THE SALES REP, (B)(6), REPORTED THAT THE SOLIS STERILE CAGE WAS FAILED. (B)(4) HAVE REQUESTED ADD'L DETAILS REGARDING THE EVENT. THE SALES REP WILL PROVIDE ADD'L DETAILS WEEK COMMENCING (B)(6) 2012. UPDATE FROM SALES REP VIA E-MAIL, (B)(6) - THE SALES REP REPORTED THAT THE SURGEON WILL BE REVISING THE PT, ALTHOUGH SHE IS WAITING TO RECEIVE ADD'L EVENT INFO FROM THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLIS STERILE CAGE IMPLANT ODP STRYKER SPINE BORDEAUX UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R