BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIRCONIA ABUTMENT

    MDR report key: 2194402 · Received July 29, 2011

    Report

    Report Number
    1043617-2011-00001
    Event Type
    Other
    Date Received
    July 29, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    WHIP MIX CORPORATION
    Product Code
    NHA
    PMA / PMN Number
    K082299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADAPTOR ABUTMENT, AND SCREW WERE ALL RETURNED TO WHIP MIX. BASED UPON VISUAL EXAMINATION, THERE IS NO EVIDENCE TO SUGGEST THE ABUTMENT FAILED. THE ADAPTOR WAS DESTROYED DURING THE REMOVAL. WHIP MIX PURCHASES THE ADAPTORS FROM STONEGLASS INDUSTRIES, AND MANUFACTURES THE ABUTMENTS USING LICENSED TECHNOLOGY FROM STONEGLASS. BEFORE WHIP MIX SHIPS ANY ABUTMENTS/ADAPTORS TO CUSTOMER DENTAL LABORATORIES, WHIP MIX CONDUCTS 100% TESTING TO ENSURE A CORRECT FIT WITH A SAMPLE ANALOG OR IMPLANT. WHEN STONEGLASS TRAINED WHIP MIX TO USE ITS LICENSED TECHNOLOGY, STONEGLASS INDICATED THAT THE ABUTMENT/ADAPTOR INTERFACE SHOULD HAVE A FRICTION FIT. ON (B)(4) 2011, WHIP MIX EXPRESSED ITS CONCERN TO STONEGLASS THAT WHIP MIX WOULD INTERMITTENTLY HAVE AN ABUTMENT/ADAPTOR INTERFACE WITH A PASSIVE FIT, RATHER THAN A FRICTION FIT. WHIP MIX DISCOVERED THIS ISSUE DURING VERIFICATION OF THE INTERFACE FIT PRIOR SHIPMENT TO CUSTOMERS. STONEGLASS REQUESTED SAMPLE ABUTMENTS ALONG WITH ADAPTORS FOR TESTING, WHICH WHIP MIX PROVIDED. ON (B)(4) 2011, CONTRARY TO ITS INSTRUCTION TO WHIP MIX REGARDING THE NECESSARY FRICTION FIT BETWEEN THE ABUTMENT AND THE ADAPTOR, A STONEGLASS TECHNICIAN STATED A PASSIVE FIT WAS PERFECTLY ACCEPTABLE AND STATED ALL THE PARTS WERE WITHIN SPECIFICATION. ON (B)(4) 2011, A DENTAL LAB CONTACTED WHIP MIX CONCERNING THIS COMPLAINT FROM ONE OF ITS CUSTOMER DENTISTS. WHIP MIX FOLLOWED UP DIRECTLY WITH THE DENTIST TO OBTAIN ADDITIONAL INFO CONCERNING THE EVENT. WHIP MIX BELIEVES THIS PASSIVE FIT PERMITTED THE ABUTMENT TO SEPARATE FROM THE ADAPTOR.

    Description of Event or Problem · 1

    A DENTIST WAS INSTALLING A REPLACE SELECT WIDE ABUTMENT WITH ADAPTOR COMPONENT. DURING THE INSTALLATION, THE DENTIST REPORTED, THE UNIT "LOCKED IN PLACE," WHICH DID NOT FEEL CORRECT TO HIM. THE DENTIST NOTICED THE ABUTMENT WAS OUT OF PLACE; THERE WAS ABOUT ONE HALF MILLIMETER BETWEEN THE MARGIN OF THE ABUTMENT AND THE GUM LINE. HE TOOK AN X-RAY THAT REVEALED THE ABUTMENT HAD BECOME SEPARATED FROM THE ADAPTOR. WHEN HE ATTEMPTED TO REMOVE THE COMBINATION ABUTMENT AND ADAPTOR, THE ABUTMENT CAME OUT, BUT THE ADAPTOR REMAINED IN THE IMPLANT. IT TOOK THE DENTIST 75 MINUTES TO REMOVE THE ADAPTOR. THERE WAS NO PT INJURY OR ADVERSE EFFECTS. THE DENTIST INDICATED IF THIS EVENT WERE TO HAPPEN AGAIN, AND THE ADAPTOR WAS NOT ABLE TO BE REMOVED, THEN SURGICAL INTERVENTION WOULD BE NEEDED TO REMOVE THE IMPLANT. TO INVESTIGATE THIS EVENT, WHIP MIX TESTED SEVEN OTHER ADAPTORS, ALL OF WHICH WERE THE SAME MODEL AS THE ADAPTOR INVOLVED IN THIS EVENT, WITH SAMPLE IMPLANTS USED FOR TESTING. FOUR ADAPTORS FIT WELL WITH THE IMPLANT, BUT THREE ADAPTORS HAD TIGHT FIT WITH THE IMPLANT. THUS, WHIP MIX BELIEVES THE ADAPTOR IN THIS CASE MAY HAVE HAD A TIGHT FIT WITH THE IMPLANT. AS OF JULY 1ST 2011, WHIP MIX IS NO LONGER MANUFACTURING ABUTMENTS USING STONEGLASS' LICENSED TECHNOLOGY, NOR USING THE STONEGLASS ADAPTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIRCONIA ABUTMENT ABUTMENT IN ZIRCONIA NHA WHIP MIX CORPORATION 49581 014678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other