BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOTOME

    MDR report key: 2666776 · Received July 24, 2012

    Report

    Report Number
    1226348-2012-00356
    Event Type
    Malfunction
    Date Received
    July 24, 2012
    Report Date
    June 25, 2012
    Product Code
    KDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. (B)(4): DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    MEDWATCH FORM REPORTED THAT A PIECE OF THE OSTEOTOME BROKE OFF WHEN IT HIT THE STAPLE. ADDITIONAL INFORMATION PROVIDED IN A PHONE CONVERSATION EXPLAINED THAT THE PRODUCT CODE IS NOT AVAILABLE. THE DEVICE WAS DISCARDED AND THERE WAS NO HARM, PHYSICAL OR OTHERWISE TO THE PATIENT AS THE BROKEN PIECE WAS VISUAL AND RETRIEVED. NO DELAY IN THE PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOTOME OSTEOTOME KDG

    Patients

    Seq Age Sex Outcome Treatment
    1