BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS TIB INSERT

    MDR report key: 1851057 · Received September 29, 2010

    Report

    Report Number
    2249697-2010-01289
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS KEPT BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. THE LOT CODE FOR THE REPORTED DEVICE WAS NOT PROVIDED. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT HAD REVISION DUE TO PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO TS TIB INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention