BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMERICAN MEDICAL SPECIALTIES, INC.

    MDR report key: 919816 · Received August 14, 2007

    Report

    Report Number
    1058412-2007-00002
    Event Type
    Other
    Date Received
    August 14, 2007
    Date of Event
    July 13, 2007
    Report Date
    August 13, 2007
    Manufacturer
    ONYX MEDICAL CORP.
    Product Code
    HTY
    PMA / PMN Number
    K960483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AMS BECAME AWARE OF THIS EVENT ON 8/13/07. IN CHECKING OUR FILES FOR THIS CUSTOMER, WE NOTED PURCHASES OF A1605-962 WERE MADE IN 2007. ALL WERE FROM THE SAME LOT, #061018ON. AMS IS NOT CERTAIN THIS IS THE LOT IN QUESTION, BECAUSE THE HOSP IS UNABLE TO PROVIDE THIS INFO. BUT, WE FEEL IT IS REASONABLE TO ASSUME PINS INVOLVED CAME FROM THIS LOT. A RECORD OF AMS RECEIVING INSPECTION SHOWS THIS LOT TO BE FROM A SHIPMENT RECEIVED ON 10/18/06 THAT CONFORMED TO ALL SPECIFICATIONS. THE LOT CONTAINED 378 PIECES. IT WAS RETURNED FROM OUR CONTRACT STERILIZER ON 11/10/06. NO OTHER CONCERNS OR COMPLAINTS HAVE BEEN RECORDED ABOUT THIS LOT OR THIS ITEM.

    Description of Event or Problem · 1

    THE FOLLOWING INFO IS FROM MEDWATCH CREATED BY USER FACILITY: PT UNDERWENT CLOSED REDUCTION AND PERCUTANEOUS PINNING FOR A SUPRACONDYLAR HUMERUS FRACTURE AND CLOSED REDUCTION AND PERCUTANEOUS PINNING RIGHT DISTAL RADIUS FRACTURE. AT ONE-MONTH FOLLOW UP, THE PINS WERE SCHEDULED TO BE REMOVED. INFECTION WAS DISCOVERED ON ONE SIDE, BUT NOT ON THE OTHER. ACCORDING TO THE HOSP, PHYSICIANS INVOLVED DO NOT BELIEVE THE STEINMANN PINS WERE TO BLAME FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SPECIALTIES, INC. STEINMANN PINN HTY ONYX MEDICAL CORP. A1605-962 061018ON*

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other