BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    430 K SW

    MDR report key: 795196 · Received December 5, 2006

    Report

    Report Number
    2520265-2006-00002
    Event Type
    Malfunction
    Date Received
    December 5, 2006
    Report Date
    December 1, 2006
    Manufacturer
    STARDENTAL
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER STARDENTAL HEALTH HAZARD EVALUATION DATED 12-01-2006, STARDENTAL HAS DETERMINED THAT SERIOUS HEALTH CONSEQUENCES DUE TO THE DISASSEMBLY OF THE END CAP PRODUCT IS EXTREMELY REMOTE. HOWEVER, DUE TO THE FACT THAT THE DISASSEMBLY OF THE END CAP PRODUCT MAY LIMIT ITS INTENDED FUNCTIONALITY, AND THAT ONE INCIDENT INVOLVING SWALLOWING OCCURRED, STARDENTAL WILL CONDUCT A RECALL OF THE PRODUCT. EVALUATION: THE END CAP WAS VISUALLY EXAMINED FOR DEFECTS THAT MAY HAVE CAUSED THE END CAP ASSEMBLY TO COME APART. THE THREADS OF THE BUTTON AND NUT WERE EXAMINED TO DETERMINE IF THERE WAS ANY RESIDUE REMAINING OF THE EPOXY USED TO BOND THE BUTTON AND THE NUT TOGETHER. THERE WAS NO RESIDUE ON THE THREADS. CONCLUSION: THE ABSENCE OF EPOXY ON THE ASSEMBLY CAUSED THE NUT TO COME LOOSE FROM THE BUTTON. THIS RESULTED IN THE BUTTON AND SPRING COMING OUT OF THE HANDPIECE AND INTO THE PATIENT'S MOUTH. RECOMMENDATION: STARDENTAL WILL REVIEW THE ASSEMBLY PROCESS TO DETERMINE IF ANY ADDITIONAL REQUIREMENTS CAN BE MADE TO ENSURE THE OPERATOR HAS APPLIED THE EPOXY AS DESCRIBED ON THE PROCESS INSTRUCTIONS.

    Description of Event or Problem · 1

    DOCTOR WAS DOING A COMPOSITE RESTORATIVE ON A MINOR PATIENT WHEN THE HANDPIECE END CAP CAME APART IN THE PATIENT'S MOUTH. A SMALL SPRING FROM THE END CAP WAS PARTIALLY SWALLOWED BY THE PATIENT. THE DOCTOR WAS ABLE TO RETRIEVE THE SPRING. THE DOCTOR REPORTED NO MEDICAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 430 K SW HIGHSPEED DENTAL HANDPIECE EFB STARDENTAL 262057 1006380

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other