BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBWEGESER INTERDENTAL OSTEOTOME, 6.5MM, 15.5CM

    MDR report key: 1486432 · Received August 7, 2009

    Report

    Report Number
    8010177-2009-00106
    Event Type
    Malfunction
    Date Received
    August 7, 2009
    Date of Event
    July 7, 2009
    Report Date
    July 8, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    EMM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS CHISELING AROUND THE SAGITTAL PLANE AND A PIECE OF THE OSTEOTOME SPLINTERED OFF INTO THE PT. THE SURGEON WAS ABLE TO RECOVER THE PIECE OF THE OSTEOTOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBWEGESER INTERDENTAL OSTEOTOME, 6.5MM, 15.5CM INSTRUMENT EMM STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention