BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITI 4.8 ESTHETIC PLUS SOLID SCREW IMPLANT-WIDE NECK

    MDR report key: 566729 · Received January 4, 2005

    Report

    Report Number
    MW1034353
    Event Type
    Injury
    Date Received
    January 4, 2005
    Date of Event
    December 20, 2002
    Report Date
    January 4, 2005
    Manufacturer
    STRAUMANN, USA
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD INFECTION SCRAPED OUT OF THE IMPLANT SITE 3 MONTHS LATER AND WAS PLACED ON ANTIBIOTICS. THE DR WHO PLACED THE IMPLANT KEPT TELLING PT NOTHING WAS WRONG EVEN THOUGH HE REMOVED GRANULATION AND SAID PT HAD AN INFECTION. PT KEPT EXPERIENCING PAIN - BURNING AND TINGLING ALONG THE LEFT HAND SIDE OF FACE. SURGEON TOLD PT TO NOT COME IN ANYMORE AND PT DID NOT SEE HIM FOR A FULL YEAR. HIS OFFICE TOLD PT TO GIVE IT TIME TO HEAL. THIS PAST APRIL 2004 THE PAIN GOT SO BAD IT WAS AFFECTING PT'S NECK. PT FELT LIKE THEIR FACE WAS IN A VICE-GRIP. PT WENT TO 12 DOCTORS INCLUDING THE ORGINIAL SURGEON - FROM MAY 2004 TILL AUGUST 2004. SOME DOCTORS TOLD PT IT WAS NOT A GOOD IMPLANT - TOO TIGHT AN AREA FOR THE WIDE CORONAL PART OF IMPLANT THAT WAS ABOVE THE BONE. SOME DOCTORS TOLD PT NOTHING WAS WRONG. PT COULD NOT TAKE THE PAIN ANYMORE SO PT DID SOME RESEARCH ON-LINE REGARDING A REFERRAL PT WAS GIVEN. AFTER PT LOOKED UP A WEBSITE OF A PROMINENT SURGEON IN THE NORTHWEST PT DECIDED TO CALL THEIR OFFICE ABOUT PROBLEM. THE OFFICE SEEMED TO BE VERY RECEPTIVE ABOUT THE PROBLEM PT WAS IN AND DECIDED TO LEAVE THE STATE SO THAT PT COULD BE SEEN AS SOON AS POSSIBLE. PT HAD A KIND SURGEON REMOVE IT. HE SAID PT HAD AN ON-GOING INFECTION - THAT THE IMPLANT APPEARED TO NEVER HAVE TOTALLY HEALED. HE SAID IT MAY HAVE BEEN CONTAMINATED OR THAT PT WAS REJECTING IT FOR SOME REASON. GENERAL DENTIST KEPT TELLING PT THEY DID NOT REJECT IT AND WAS FRUSTRATED WHY PT KEPT HAVING PAIN. SHE SAID IT APPEARED TO HAVE INTEGRATED WELL ON AN X-RAY. PT LOOKED IT UP ON THE FDA WEBSITE AND FOUND IT WAS RECALLED IN APRIL 2000. PT CALLED THE COMPANY THAT MAKES THESE IMPLANTS AND THEY SAID THEY HAVE A NEW AND IMPROVED VERSION OF THESE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITI 4.8 ESTHETIC PLUS SOLID SCREW IMPLANT-WIDE NECK TITANIUM DENTAL IMPLANT DZE STRAUMANN, USA * 1041

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R