BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOND TOTAL ETCH

    MDR report key: 2930444 · Received January 9, 2013

    Report

    Report Number
    9610902-2013-00014
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 13, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K083652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSE OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF AN ABUNDANCE CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. A UPS LABEL WAS SENT TO THE OFFICE AND A FOLLOW-UP CALL HAS BEEN MADE TO RETRIEVE THE DEVICE, BUT THE OFFICE THUS FAR HAS BEEN UNRESPONSIVE. METHOD: THIS IS THE ONLY COMPLAINT FOR DEBONDING RECEIVED ON THIS DEVICE BATCH WHICH HAS BEEN IN USE FOR 28 MONTHS. CONCLUSIONS: THE OFFICE DID NOT USE A RUBBER DAM FOR ISOLATION. THEY USE COTTON ROLLS AND DRY ANGLES FOR ISOLATION. THE DIRECTIONS FOR USE STATES, "THE USE OF A RUBBER DAM IS RECOMMENDED." THE ISOLATION METHOD USED BY THE OFFICE DOES NOT PROVIDE COMPLETE ISOLATION FROM THE ORAL ENVIRONMENT DURING RESTORATIVE PROCEDURES. THERE IS STILL A POTENTIAL FOR SALIVA, BLOOD AND WATER TO CONTAMINATE THE TREATMENT AREA. CONTAMINATION OF THE TREATMENT AREA IS KNOW NOT CAUSE BOND FAILURE. THE COMPLAINT IS NOT VALID. IT IS FOR THE AFOREMENTIONED REASONS THAT CAPA MEASURES WILL NOT BE RECOMMENDED OR INITIATED.

    Description of Event or Problem · 1

    THIS IS THE FOURTEENTH OF TWENTY REPORTS FOR THE SAME DENTAL OFFICE. THERE ARE NO PATIENT OR INCIDENT DETAILS AS THE ASSISTANT DID NOT WANT TO PULL ALL THE CHARTS. SHE HOWEVER GAVE GENERAL INFORMATION ON THE INCIDENCES. SPOKE TO ASSISTANT. SHE SAID THEY ARE HAVING TROUBLE WITH FILLINGS FALLING OUT. SHE SAID 15 TO 20 PATIENTS HAD CALLED WITHIN A DAY OF THEIR RESTORATIVE APPOINTMENTS AND COMPLAINED THEIR FILLINGS HAD FALLEN OUT. SHE SAID THEY HAVE THEM RETURN TO THE OFFICE IMMEDIATELY AND REPLACE THE FILLINGS. SHE SAID THEY HAVE 2 OPEN BOXES OF IBOND TE, BUT ALL OF THE FILLINGS THAT NEED REPLACED ARE COMING FROM THIS BOX. SHE SAID THEY HAVE REPLACED THE FILLINGS ARE OT FALLING OUT. SHE SAID THEY ARE AFRAID SOMETHING IS WRONG WITH THE IBOND TE IN THIS ONE BOX. SHE SAID THAT THIS HAS ALL BEEN GOING ON OVER THE LAST WEEK OR SO AND THE DENTISTS WILL NOT USE THE SINGLE DOSES FROM THIS BOX ANYMORE AND WANT A NEW BOX. SHE SAID THAT ALL THE COMPOSITES PLACED WERE A 3M COMPOSITE MATERIAL. SHE SAID THAT THEY HAVE REPLACED ALL OF THE FILLINGS FROM THIS BOX AND THAT ALL OF THE PATIENTS ARE FINE AND THEY HAVE NOT RECEIVED ANY MORE COMPLAINTS OF FILLINGS FALLING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10559 IBOND TOTAL ETCH KLE AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH 010035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention