BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-TRALIG INTRLGMNTRY SYRG

    MDR report key: 6975447 · Received October 25, 2017

    Report

    Report Number
    2523190-2017-00120
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    August 28, 2017
    Report Date
    October 5, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EJI
    PMA / PMN Number
    K142414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    10/16/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - THE CUSTOMER SUPPLIED PICTURES INDICATE NECROTIC TISSUE AT INJECTION SITE. THE CAUSE FOR THE NECROTIC TISSUE CAN NOT BE DETERMINED AS THE NEEDLE, LIDOCAINE, AND PROCESS DURING THE PROCEDURE IS NOT KNOWN. THE COMPLAINT IS CONFIRMED. DEVICE HISTORY EVALUATION - ANY APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. ANY APPLICABLE VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ANY APPLICABLE ENGINEERING CHANGE ORDER / MANUFACTURING CHANGE ORDER HISTORY: NONE. ANY APPLICABLE CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE CUSTOMER SUPPLIED PICTURES INDICATE NECROTIC TISSUE AT INJECTION SITE. ROOT CAUSE UNDETERMINED. THERE HAS BEEN NO MANUFACTURING DEFICIENCY IDENTIFIED.

    Description of Event or Problem · 1

    DOCTOR INITIALLY REPORTS THE SYRINGE CREATED NECROTIC TISSUE AT THE INJECTION SITE. ON (B)(6) 2017 DOCTOR REPORTS ANESTHETIC USED: SEPTOCAINE 1:200,000 - APPROXIMATELY 1/3-1/2 CARPULE INJECTED AT CERVICAL OF FACIAL SURFACE OF TOOTH AT GUM LINE UNDER PRESSURE AT 3 SITES MESIAL PROXIMAL, FACIAL, DISTAL PROXIMAL. CHLORHEXIDINE RINSE CLEARED UP THE AREA. AREA RESOLVED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755021 N-TRALIG INTRLGMNTRY SYRG M51 - GENERAL DENTISTRY EJI INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR