BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-OSTEOTOME, STRAIGHT, 2MM

    MDR report key: 170835 · Received May 29, 1998

    Report

    Report Number
    1037007-1998-00001
    Event Type
    Injury
    Date Received
    May 29, 1998
    Date of Event
    April 28, 1998
    Report Date
    May 28, 1998
    Manufacturer
    SMITH & NEPHEW, INC. ENT DIV.
    Product Code
    JYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER TAPPING ON THE OSTEOTOME, THE PHYSICIAN THOUGHT THAT THE INSTRUMENT LOOKED SHORTER THAN BEFORE USE. HE THOUGHT THAT IT WOULD BE BETTER TO LEAVE THE PIECE IN THE BONE RATHER THAN REMOVE IT. FLUOROSCOPY INDICATED THAT A PIECE OF THE INSTRUMENT LESS THAN 2 MM WAS LEFT LODGED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-OSTEOTOME, STRAIGHT, 2MM INSTRUMENT JYE SMITH & NEPHEW, INC. ENT DIV. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other