BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAUMANN

    MDR report key: 2059310 · Received April 11, 2011

    Report

    Report Number
    MW5020246
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    January 4, 2010
    Report Date
    April 11, 2011
    Manufacturer
    STRAUMANN USA, LLC
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2010 I HAD A DENTAL IMPLANT INSTALLED IN LOCATION OF BOTTOM LEFT MOLAR TO ALLOW SUBSEQUENT INSTALLATION OF DENTAL CROWN. THE IMPLANT WAS A STRAUMANN 4.8MM WN SL ACTIVE 10MM, LOT#J2119 REFERENCE NUMBER (B)(4). IMPLANT SURGERY WAS SUCCESSFUL AND I EXPERIENCE NO ADVERSE EFFECTS. SUBSEQUENT F/U VISIT DEEMED IMPLANT WAS HEALING FINE. APPROX 9 MONTHS LATER I VISITED MY DENTIST TO HAVE CROWN MADE FOR INSTALLATION ONTO IMPLANT. MY DENTIST COULD NOT REMOVE THE "HEALING CAP" THAT WOULD NOT ALLOW CROWN TO SCREW INTO/MOUNT ONTO IMPLANT. I VISITED MY SURGEON WHO INSTALLED IMPLANT TO HAVE HIM REMOVE HEALING CAP, HE ATTEMPTED REMOVAL BUT ENDED UP BREAKING OFF REMOVAL TOOL WITHIN IMPLANT. HE CONSULTED WITH MFR, WHO AFTER EXTENDED DELAY BECAUSE THE "REMOVAL TOOLS WHERE IN LIMITED QUANTITY AND WERE BEING USED WITH OTHER PTS WHO HAD SAME PROBLEM, SUPPLIED MY SURGEON WITH A SPECIAL "REMOVAL TOOL". I AGAIN VISITED MY SURGEON FOR ANOTHER ATTEMPT AT HEALING CAP REMOVAL. AFTER 2 HRS IN THE CHAIR AND LOTS OF DRILLING, GRINDING, POUNDING, HE INFORMED ME THAT HE COULD NOT GET HEALING CAP OFF, THAT THE TOOLS SENT APPEARED TO BE "DULL" AND THAT HE WOULD CONTACT VENDOR FOR CONSULT AND NEW TOOLS. NEW TOOLS WERE OBTAINED AND I AGAIN VISITED MY SURGEON FOR ATTEMPTED REMOVAL OF HEALING CAP. HE WAS ABLE TO DRILL HOLE INTO HEALING CAP AND INSERTION OF AN "EASY OUT" REVERSE SCREW TYPE DEVICE. THE EASY OUT BROKE OFF WITH A PIECE OF IT LODGED WITHIN HEALING CAP. I ASKED MY SURGEON TO AGAIN CONSULT WITH MFR AND PROVIDE ME SPECIFICS ON IMPLANT DEVICE, A CONTACT I COULD SPEAK WITH AT (B)(6) AND MY OPTIONS MOVING FORWARD. MY SURGEON GOT BACK TO ME AND TOLD ME THAT I CAN NOT SPEAK WITH (B)(6), THAT THEY TOLD HIM THEY WERE NOT ALLOWED TO SPEAK DIRECTLY WITH PTS. HE EXPLAINED MY OPTIONS, ATTEMPT AGAIN HEALING CAP REMOVAL, ABANDON IMPLANT AND BUILD BRIDGE ACROSS ADJOINING TEETH, REMOVE IMPLANT, LET IT HEAL AND INSTALL NEW IMPLANT. AFTER A YEAR AND A HALF OF EFFORTS OF TRYING TO GET A NEW CROWN I AM FACED WITH A DEFECTIVE IMPLANT AND LOTS OF TIME IN THE CHAIR TO GET THIS PROBLEM RESOLVED. I PLAN TO CONSULT ANOTHER SURGEON FOR ADVICE, I HAVE NOT MADE A DECISION YET ON HOW TO PROCEED MOVING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAUMANN DENTAL IMPLANT NHA STRAUMANN USA, LLC 4.8MM WN, SLACTIVE J2119

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability