BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTI INTER FLEX DS DIAMOND DISC

    MDR report key: 7661568 · Received July 3, 2018

    Report

    Report Number
    1645240-2018-00001
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 4, 2018
    Report Date
    October 12, 2018
    Manufacturer
    NTI-KAHLA GMBH
    Product Code
    DZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ND, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE EVALUATION FROM THE MANUFACTURER IS THE PRODUCT ARE LABORATORY INSTRUMENTS WHICH ARE NOT SUITABLE FOR USE ON PATIENTS. ON THE PACKAGING IT WILL STATE THE INSTRUMENT WILL NOT BE USED IN THE MOUTH.

    Description of Event or Problem · 0

    AN ALLEGED COMPLAINT WAS REPORTED THAT THE DIAMOND DISC SHATTERED AND PENETRATED THE PATIENTS LIP. STAFF APPLIED COMPRESSION, FLUSHED THE AREA AND SUTURED THE WOUND CLOSE. THE PATIENT REQUIRED A TOTAL OF 7 STITCHES. PATIENT HAD SWELLING WITH BRUISING ON THEIR LIP DURING A FOLLOW UP. PATIENTS LIP IS HEALING, BUT THERE IS SCAR TISSUE. NO OTHER COMPLAINTS AND OR COMPLICATION REPORTED.

    Description of Event or Problem · 1

    AN ALLEGED COMPLAINT WAS REPORTED THAT THE DIAMOND DISC SHATTERED AND PENETRATED THE PATIENTS LIP. STAFF APPLIED COMPRESSION, FLUSHED THE AREA AND SUTURED THE WOUND CLOSE. THE PATIENT REQUIRED A TOTAL OF 7 STITCHES. PATIENT HAD SWELLING WITH BRUISING ON THEIR LIP DURING A FOLLOW UP. PATIENTS LIP IS HEALING, BUT THERE IS SCAR TISSUE. NO OTHER COMPLAINTS AND OR COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499980 NTI INTER FLEX DS DIAMOND DISC INSTRUMENT, DIAMOND, DENTAL DZP NTI-KAHLA GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other