BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA LUX HEAD 68 LDN

    MDR report key: 6445904 · Received March 30, 2017

    Report

    Report Number
    3003637274-2017-00020
    Event Type
    Injury
    Date Received
    March 30, 2017
    Report Date
    March 30, 2017
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EGS
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN SOLD IN 06/1995 TO THE CUSTOMER. SINCE THAT TIME, IT HAS NEVER BEEN RETURNED FOR A SERVICE CHECK WHICH IS REQUIRED ON A REGULAR BASE DEPENDING ON THE FREQUENCY OF USE. UNFORTUNATELY, CUSTOMER IS NOT WILLING TO SUPPLY A REPAIR HISTORY. ONLY THE HEAD HAS BEEN AVAILABLE FOR THE ANALYSIS, THE SWALLOWED BACK CAP HAS BEEN MISSING. HOWEVER THIS WOULD HAVE BEEN A VERY IMPORTANT PART TO GET A COMPLETE VIEW OF THE SITUATION. THE HEAD HAD SEVERAL NICKS ALL AROUND WHICH INDICATES THAT IT RECEIVED EXTERNAL FORCE, E.G. HITS. SUCH HITS COULD CAUSE THAT THE BACK CAP GETS UNLOCKED. IF IT GETS USED FURTHER THE VIBRATIONS COULD CAUSE THAT IT UNSCREWS FURTHER AND DROPS FINALLY OFF THE HEAD. IF THE FUNCTIONAL AND VISUAL TEST IS DONE PRIOR TO EACH TREATMENT AS REQUESTED BY THE IFU IT WOULD BE RECOGNIZABLE THAT THE BACK CAP IS LOOSE AND SHOULD BE RE-TIGHTENED AGAIN. INCIDENT GETS REPORTED AS SIMILAR PRODUCTS GET SOLD IN USA.

    Description of Event or Problem · 1

    IT WAS DESCRIBED THAT DURING A STANDARD DENTAL TREATMENT THE BACK CAP OF THE INSTRUMENT CAME LOOSE AND FELL INTO PATIENTS MOUTH. PATIENT THEN SWALLOWED THE BACK CAP. AN X-RAY SHOWED THAT IT WAS IN THE STOMACH. NO FURTHER MEDICAL CARE NECESSARY. THE DENTAL OFFICE DIDN'T WANT TO SUPPLY FURTHER DATA, HENCE DATE OF EVENT AND PATIENT DATA ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230280 INTRA LUX HEAD 68 LDN DENTAL HEAD ATTACHMENT EGS KAVO DENTAL GMBH 68 LDN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other