BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2221624 · Received August 19, 2011

    Report

    Report Number
    2520274-2011-00564
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    July 26, 2011
    Manufacturer
    NI
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NAME, MFR AND 510K CANNOT BE DETERMINED WITHOUT A PART NUMBER AND LOT NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(6), INDICATES THE PT WAS IMPLANTED ON (B)(6) 2011 FOR A LEFT DISTAL RADIUS FRACTURE. X-RAY TAKEN ON (B)(6) 2011 SHOWED THE PLATE TO BE BROKEN. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2011 FOR REMOVAL OF THE BROKEN PLATE AND STABILIZATION WITH AN EXTERNAL FIXATION DEVICE. THIS IS THE SECOND OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI SCREW HWC NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention PLATE