BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STD HUM BEARING/BUSHING KIT

    MDR report key: 1871283 · Received October 13, 2010

    Report

    Report Number
    2249697-2010-01347
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSD
    PMA / PMN Number
    K062845
    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 RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MFR. THE LOT CODE FOR THE REPORTED DEVICE WAS NOT PROVIDED. ADD'L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2010-01345.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT HAD A SEIZURE AND FELL ON HIS ELBOW, CAUSING THE PIN TO COME OUT AND THE PLASTIC TO BREAK. REVISION TO REPLACE THESE PARTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STD HUM BEARING/BUSHING KIT IMPLANT HSD STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention