BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHEX ONE PIECE ONE-STAGE DENTAL IMPLANT AND RESTORATIVE SY

    MDR report key: 1976698 · Received January 28, 2011

    Report

    Report Number
    MW5019209
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    May 2, 2005
    Report Date
    January 21, 2011
    Manufacturer
    BIOMEDICAL IMPLANT TECHNOLOGY INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DENTIST INSTALLED MULTIPLE BIOHEX ONE PIECE ONE-STAGE DENTAL IMPLANTS ("BIOHEX") IN THE PT BETWEEN 2003 AND 2005 WITHOUT OBTAINING PT'S INFORMED CONSENT. AT LEAST TWO IMPLANTS FAILED AND HAD TO BE REMOVED. ADD'L TWO IMPLANTS BROKE AND NEED IMMEDIATE REPLACEMENT. DENTIST FAILED TO NOTIFY THE PT THAT HE IS THE ONLY INDIVIDUAL THAT PRACTICES WITH BIOHEX IN THE (B)(6) AND (B)(6) AND THAT NO OTHER SERVICE FOR BIOHEX IMPLANTS IS AVAILABLE IN THE REGION. DENTIST ALSO FAILED TO NOTIFY THE PT ABOUT THE RARITY AND UNPOPULARITY OF THIS DENTAL IMPLANT. IN (B)(6) OF 2005, DENTIST REFUSED TO PROVIDE DENTAL SERVICES TO THE PT AND ATTEND TO MALFUNCTIONING BIOHEX IMPLANTS DESPITE PT'S COMPLAINTS AND PLEADINGS FOR HELP. IN 2006, PT TRAVELLED FROM (B)(6) TO THE MFR'S FACILITY LOCATED IN (B)(4) TO RECEIVE TREATMENT FROM THE (B)(4). PT HAD TO TRAVEL TO (B)(6) TO OBTAIN RELIEF FROM CONSTANT PAIN FROM THE BIOHEX IMPLANTS AND BECAUSE NO OTHER DENTIST IN (B)(6) AND (B)(6) WAS FAMILIAR WITH BIOHEX. AS THE ORIGINAL DENTIST REFUSED TO PROVIDE TREATMENT OR SERVICE ON THE MALFUNCTIONING BIOHEX IMPLANTS HE INSTALLED, THE PT DID NOT HAVE A CHOICE. IN THE (B)(4) OFFICE OF THE BIOMEDICAL IMPLANT TECHNOLOGY INC LOCATED AT (B)(4), AS THE (B)(4) OF THE BIOHEX DENTAL IMPLANT, THE PT RECEIVED ADD'L TREATMENT. AS THE (B)(4) OF THE BIOHEX DENTAL IMPLANT SYSTEM, THIS IS THE SECOND KNOWN DR THAT KNOWS HOW TO TREAT THE TEETH WITH BIOHEX. HE INSTALLED ADD'L BIOHEX IMPLANTS. TODAY INSTALLED BIOHEX IMPLANTS REQUIRE IMMEDIATE ADD'L WORK, ARE NOT FUNCTIONING PROPERLY, HAVE CRACKED AND ARE BROKEN, ARE UNSTABLE, AND NEED IMMEDIATE REPLACEMENT. SOME ARE CRACKED, SOME CAUSE GUM IRRITATION, AND SOME ARE ABOUT TO BREAK ONLY AFTER 4 YEARS IN USE. NO DENTIST IN (B)(6) KNOWS HOW TO TREAT AND ATTEND TO THESE MALFUNCTIONING BIOHEX IMPLANTS. THE (B)(4) OF BIOHEX IN BIOMEDICAL IMPLANT TECHNOLOGY INC IN (B)(4) REFUSES TO PRODUCE PT'S MEDICAL RECORD OR PROVIDE HELP AND FIX THE BIOHEX IMPLANTS. TODAY, THE PT IS STUCK BETWEEN A ROCK AND HARD PLACE. HE HAS MALFUNCTIONING BIOHEX IMPLANTS WITHOUT ANYONE TO SERVICE THEM. THE ONLY TWO KNOWN INDIVIDUALS THAT KNOW HOW TO SERVICE BIOHEX IMPLANTS REFUSED SERVICE AND REFUSE TO CO-OPERATE. PT NEEDS IMMEDIATE HELP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHEX ONE PIECE ONE-STAGE DENTAL IMPLANT AND RESTORATIVE SY BIOHEX ONE PIECE ONE-STAGE DENTAL IMPLANT DZE BIOMEDICAL IMPLANT TECHNOLOGY INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R| S