BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT TEASER #36 X-DELICATE, SERRATED

    MDR report key: 1997479 · Received February 22, 2011

    Report

    Report Number
    1032347-2011-00019
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EKR
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL INSPECTION OF THE INSTRUMENT CONFIRMED THE TIP OF ONE END IS BROKEN OFF. THE PRODUCT WAS MANUFACTURED IN 1996. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TRYING TO REMOVE A PIECE OF ROOT FROM A TOOTH, THE ROOT TEASER TIP BROKE, AND THE PATIENT SWALLOWED IT. THE X-RAY LOCATED THE TIP IN THE PATIENT'S INTESTINE. THE PATIENT WAS ADVISED NO SURGERY WAS NEEDED TO REMOVE THE TIP AS IT WILL PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROOT TEASER #36 X-DELICATE, SERRATED ROOT TEASER EKR BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization