BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVITRON

    MDR report key: 512165 · Received February 3, 2004

    Report

    Report Number
    MW1031080
    Event Type
    Injury
    Date Received
    February 3, 2004
    Date of Event
    December 8, 2003
    Report Date
    February 3, 2004
    Manufacturer
    DENTSPLY INTL, INC.
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DENTAL TECHNICIAN WAS PERFORMING AN ORAL PROPHYLAXIS ON A PT USING A DENTSPLY CAVITRON. THE TIP OF THE INSTRUMENT BROKE OFF AND LANDED ON THE PT'S TONGUE. THE TECHNICIAN WAS NOT ABLE TO RETRIEVE THE TIP BEFORE THE PT SWALLOWED IT. THE PT WAS IMMEDIATELY TAKEN TO FAMILY MEDICINE WHERE THE TIP WAS RETRIEVED. THE PT DID NOT SUFFER ANY INJURIES. FACILITY'S DENTAL INVESTIGATION SERVICE WAS CONTACTED TO IDENTIFY IF ANY OTHER COMPLAINTS HAVE BEEN SUBMITTED CONCERNING CAVITRON TIPS. NO OTHER COMPLAINTS HAD BEEN SUBMITTED CONCERNING CAVITRON TIPS AND REQUESTED THAT REPORTER SEND THE BROKEN CAVITRON TIP TO ANALYZE WHY THE TIP BROKE, ALSO CONTACTED MANUFACTURER. THE MANAGER OF REGULATORY AFFAIRS STATED THAT THE TFI-1000 CAVITRON TIP IS ONE OF THEIR MORE DURABLE CAVITRON TIPS AND THAT IT WAS RARE FOR THIS PARTICULAR MODEL OF CAVITRON TIP TO BREAK. HE ALSO NOTED THAT SINCE 1999 THERE HAVE BEEN MORE THAN 64,600 TFI-1000 INSERTS MANUFACTURED AND A TOTAL OF 167 COMPLAINTS HAVE BEEN SUBMITTED TO THEM. OF THE 167 COMPLAINTS SUBMITTED 112 OF THESE COMPLAINTS DEMONSTRATED EVIDENCE OF EXCESSIVE WEAR AND ABUSE OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAVITRON ULTRASONIC INSERT TIPS ELC DENTSPLY INTL, INC. CAVITRON *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention