BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK TI-MAX AK450L SU

    MDR report key: 4766039 · Received May 8, 2015

    Report

    Report Number
    9611253-2015-00076
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    January 26, 2015
    Report Date
    May 7, 2015
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EFB
    PMA / PMN Number
    K962543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM NSK AMERICA CORP TO NAKANISHI INC (NSK) REGARDING A DEVICE MANUFACTURED BY NSK. EVENT SUMMARY: ON (B)(6) 2015 NSK AMERICA CORP WAS MADE AWARE THAT A PT HAD BEEN INVOLVED IN AN EVENT WHERE A HANDPIECE HEAD HAD DETACHED WHILE IN USE. THE HANDPIECE MODEL IS AK450L SU SN (B)(4). NSK AMERICA CORP RECEIVED THE SUBJECT HANDPIECE ON 4/1/2015 FROM THE DENTIST. NSK AMERICA ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION FROM THE DENTIST OFFICE SEVERAL TIMES AND HAS NOT RECEIVED ANY RESPONSE. NAKANISHI IS NOW INVESTIGATING THIS EVENT AND WILL SUBMIT ADDITIONAL INFORMATION INCLUDING RESULTS OBTAINED THROUGH THE INVESTIGATION AS A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304245 NSK TI-MAX AK450L SU HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI, INC. AK450L SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other