BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAUTREY ARCH BAR, 15CM

    MDR report key: 3205585 · Received July 3, 2013

    Report

    Report Number
    0008010177-2013-00149
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    EHO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. VISUAL INSPECTION REVEALED THAT THE EDGES OF THE CURRENT ARCH BARS ARE VERY SHARP. HOWEVER, WITHIN FUNCTIONAL INSPECTION THE REPORTED EVENT COULD NOT BE REPRODUCED. ALSO A COMPARISON WITH THE CURRENT DRAWING HAS SHOWN THAT THE PRODUCTS MEET THE SPECIFICATION. TO ADDRESS THE CUSTOMER CONCERNS A CHANGE REQUEST WAS INITIATED ON 2014-MAR-10 TO REDESIGN THE ARCH BAR IN A WAY IT GETS SMOOTHER. AS A PART OF THE REDESIGN THE EDGES WILL BE NEW DEFINED (ROUNDED OFF) AND THE PEGS MORE CURVED. THE CHANGE REQUEST IS STILL ONGOING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARCH BAR HAS EDGES. IT PULLS OR TEARS GUMS. THE RAIL IS VERY EDGY. THE CUSTOMER USED A DIFFERENT PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARCH BAR HAS EDGES. IT PULLS OR TEARS GUMS. THE RAIL IS VERY EDGY. THE CUSTOMER USED A DIFFERENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304993 DAUTREY ARCH BAR, 15CM ARCH BAR EHO STRYKER LEIBINGER FREIBURG 6000008880

    Patients

    Seq Age Sex Outcome Treatment
    1