BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA COMFORT BOND+DESENSITIZER

    MDR report key: 2970223 · Received February 13, 2013

    Report

    Report Number
    9610902-2013-00028
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 17, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K992292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY (B)(4), HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF AN ABUNDANCE OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. CONCLUSION - THE OFFICE ASSISTANT DESCRIBED THE USAGE AS APPLYING 2 TO 3 COATS. THE DIRECTIONS STATE, "DISPENSE GLUMA COMFORT BOND + DESENSITIZER INTO A WELL, SOAK THE APPLICATOR TIP OR A SOFT DISPOSABLE BRUSH, AND APPLY A COPIOUS AMOUNT TO THE ENTIRE CAVITY SURFACE. APPLY TWO ADDITIONAL COATS OF GLUMA COMFORT BOND + DESENSITIZER AND WAIT FOR 15 SECONDS." THE THIRD COAT MUST BE APPLIED AS THE FILM THICKNESS WILL NOT BE SUFFICIENT TO HOLD THE FILLING MATERIAL. THE OFFICE ALSO FAILED TO AIR DRY THE BONDING AGENT, AS DIRECTED IN THE DIRECTIONS FOR USE, PRIOR TO CURING. THE AIR DRYING EVAPORATES THE SOLVENT AND IS NECESSARY FOR PROPER CURING OF THE BONDING AGENT. IF THE BONDING AGENT WAS NOT COMPLETELY CURED THE BOND WILL FAIL. THE OFFICE ALSO FAILED TO VERIFY THAT THE BONDING AGENT WAS UNIFORMLY COATED ON THE PREPARED TOOTH SURFACE PRIOR TO BONDING. AREAS OF THE PREPARATION MAY HAVE BEEN LEFT UNCOATED AND THIS WILL CAUSE BOND FAILURE. THE BOND FAILURE IS DUE TO USER ERROR/MISUSE AS THE USER FAILED TO USE THE BONDING AGENT ACCORDING TO THE DIRECTIONS FOR USE. NO CAPA MEASURES ARE RECOMMENDED DUE TO THE AFOREMENTIONED USER ERROR/MISUSE.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF THREE REPORTS ON ONE DEVICE. ON (B)(6) 2012, DENTAL ASSISTANT WITH THE DENTAL OFFICE CALLED BECAUSE THEY HAVE HAD FILLINGS FALL OUT ON THREE PATIENTS. THEY USE GCB&D AND HERCULITE BY KERR. SHE SAID THAT THEY ONLY KEEP ONE BOTTLE AT A TIME IN THE OFFICE AND THIS LAST BOTTLE HAD A FEW FAILURES. THEY STORE THEIR COMPOSITE IN THE REFRIGERATOR EVERY NIGHT AND TAKE IT OUT JUST BEFORE SEEING THE FIRST PATIENT OF THE DAY. DISCUSSED THAT THE GCB&D DOES NOT NEED TO BE REFRIGERATED OVERNIGHT. THEY PREP THE TOOTH, ETCH, RINSE, DRY, AND APPLY 203 LAYERS OF GCB&D THEN LIGHT CURE FOR 20 SECONDS. DISCUSSED THAT 3 LAYERS ARE THE MINIMUM LAYERING AND THAT 2 LAYERS MAY NOT PROVIDE ADEQUATE BOND STRENGTH. DISCUSSED THAT GCB&D SHOULD RECEIVE A GENTLE AIR DRY PRIOR TO LIGHT CURING AND THAT AT THIS TIME THE MATERIAL SHOULD BE CHECKED FOR A UNIFORM GLOSSY APPEARANCE. THEN THE MATERIAL CAN BE LIGHT CURED IF THE UNIFORM GLOSSY APPEARANCE IS VISUALIZED. SHE SAID THAT SHE WOULD SHARE THIS WITH THE DENTIST. PT.1 - MALE (B)(6), TOOTH #4-O, PLACED (B)(6) 2012, DEBONDED AND REPLACED ON (B)(6) 2012. SHE SAID ALL THREE PATIENTS HAVE BEEN REPLACED AND ARE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64296 GLUMA COMFORT BOND+DESENSITIZER KLE AGENT, TOOTH BONDING RESIN KLE HERAEUS KULZER GMBH 010208

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention