BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM

    MDR report key: 6115426 · Received November 19, 2016

    Report

    Report Number
    2320721-2016-00061
    Event Type
    Malfunction
    Date Received
    November 19, 2016
    Report Date
    October 20, 2016
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    DZM
    PMA / PMN Number
    K990511
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE THE DEVICE MALFUNCTIONED AND THAT MALFUNCTION RESULTED IN A SERIOUS INJURY, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN X-RAY WAS TAKEN ON A PATIENT SIX MONTHS AFTER AN X-TIP WAS USED DURING A DENTAL PROCEDURE. THE X-RAY SHOWED A PIECE OF THE X-TIP WAS EMBEDDED IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766468 X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM NEEDLE, DENTAL DZM DENTSPLY TULSA DENTAL SPECIALTIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention