BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRA TECH DENTAL IMPLANT SIZE 3

    MDR report key: 1081164 · Received July 23, 2008

    Report

    Report Number
    MW5007776
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ASTRA TECH
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ASTRA TECH DENTAL IMPLANTS WERE PLACED AT TOOTH SITE #23 AND #25 IN 2008. WITHIN THE FIRST 4 DAYS POST OP, ISSUES BEGAN. ON THE FOLLOWING MONTH PURULENT DRAINAGE WAS OBSERVED. MANDATORY SURGERY ON THE NEXT DAY. BOTH IMPLANTS FAILED TO INTERGRATE WITH THE BONE. THE BONE APPEARED "MOTH EATEN" THE IMPLANTS WERE LOOSE AND HAD TO BE REMOVED. DUE TO THE CONDITION OF THE BONE, THE DECISION WAS MADE TO NOT INTRODUCE A BONE GRAFTING MATERIAL, TO LET THE BODY HEAL THE BONE ON ITS OWN. DUE TO THE BONE DESTRUCTION THERE WILL NEVER BE ANOTHER OPPORTUNITY TO PLACE IMPLANTS IN THIS REGION OF THE JAW AGAIN. IT APPEARS THAT THE NERVES IN TOOTH # 22 AND # 27 HAVE BEEN DAMAGED/AFFECTED ALSO. THERE IS ALSO GUM TISSUE RECESSION AT TOOTH #22 AND # 27. I HAVE NOT BEEN TOLD IF THIS GUM TISSUE WILL RECOVER. THESE ARE NATURAL TEETH AND GUM TISSUE THAT ARE DIRECTLY ADJACENT TO THE IMPLANTS. THE XRAYS, CT SCAN AND SITE SELECTION FOR THESE IMPLANTS PRIOR TO THIS IMPLANT SEATING GAVE A PROJECTED FAVORABLE OUTCOME, I HAD A SIZE 5 INNOVA IMPLANT SEATED AT # 32 IN EARLY 2007 AND THERE WAS ABSOLUTELY NO PROBLEM WITH THIS IMPLANT. I AM NOT SURE WHAT THE FUTURE TREATMENTS AND FOLLOW UP IS GOING TO BE AT THIS TIME. ASTRA TECH DENTAL PRODUCTS MANAGER WAS SENT A CERTIFIED LETTER JULY 23-08, INFORMING ASTRA TECH OF THIS SITUATION.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 07/10/2012: I AM NOTIFYING YOU, I HAD TWO OF YOUR 3.0 IMPLANTS (REF #24882, LOT #55957) PLACED ON (B)(6) 2008 AT TOOTH #23 AND #25. WITHIN A FEW DAYS OF THE IMPLANT PLACEMENTS, SYMPTOMS BEGAN. THERE WAS MULTIPLE COMMUNICATIONS AND VISITS WITH THE SURGEON. I NOTED PURULENT DRAINAGE COMING FROM THE SURGICAL SITE ON JULY (B)(6) 2008. SURGICAL INTERVENTION WAS MANDATORY AND TOOK PLACE ON (B)(6) 2008. THERE WAS A TOTAL FAILURE OF BOTH IMPLANTS TO INTEGRATE WITH THE BONE. THE BONE APPEARED "MONTH EATEN". THE IMPLANTS WERE REMOVED AND THE CLINICAL DECISION WAS MADE TO CLOSE THE WOUND AND LET MY BODY HANDLE THE HEALING PROCESS VERSUS ADDING A BONE GRAFTING MATERIAL INTO THE WOUND SITE BASED ON THE CONDITIONS OF THE BONE. DUE TO THE BONE DESTRUCTION, I WILL NEVER HAVE IMPLANTS PLACED WITHIN THIS REGION OF MY JAW EVER AGAIN. THERE APPEARS TO BE NERVE DAMAGE AT TOOTH #22 AND #27. I FIND IT THOUGHT PROVOKING THAT THESE TEETH ARE DIRECTLY ADJACENT TO BOTH OF THESE FAILED IMPLANTS. THERE IS ALSO GUM TISSUE RECESSION AT BOTH TOOTH #22 AND #27. AT THIS TIME, I AM IN QUESTION IF THE GUM TISSUE AT #22 AND #27 WILL EVER RECOVER.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 07/16/2012: I NOTIFIED (B)(4) ON JULY 23, 2008 THAT I HAD TWO OF YOUR 3.0 IMPLANTS (REF #24882, LOT #55957) PLACED ON (B)(6) 2008 AT TOOTH #23 AND #25. I NOTED PURULENT DRAINAGE COMING FROM THE SURGICAL SITE ON (B)(6) 2008. SURGICAL INTERVENTION WAS MANDATORY AND TOOK PLACE ON (B)(6) 2008. THERE WAS A TOTAL FAILURE OF BOTH IMPLANTS TO INTEGRATE WITH THE BONE. THE BONE APPEARED "MOTH EATEN" AND WAS DESTROYED. I WAS TOLD BY THE SURGEON THAT THE IMPLANTS WERE RETURNED TO YOUR COMPANY AND THAT A FAILURE "REPORT" WAS TO FOLLOW REGARDING YOUR FINDINGS. I WAS TOLD BY THE SURGEON THAT HE HAD SPOKEN TO REPS FROM YOUR COMPANY AT TWO RECENT DENTAL MEETINGS IN SEPTEMBER INQUIRING ABOUT THIS REPORT. I SPOKE TO (B)(4) ON SEPTEMBER 23, 2008 INQUIRING ABOUT THIS REPORT AND WAS INFORMED THAT THIS REPORT CAME FROM (B)(4) AND SHE WOULD LOOK INTO IT. I WAS ALSO INFORMED THAT THIS REPORT WOULD BE SENT DIRECTLY TO THE SURGEON. IT HAS BEEN ALMOST YET ANOTHER MONTH AND ALMOST 13 WEEKS POST A 200% FAILURE OF YOUR PRODUCT AND I STILL HAVE HEARD NOTHING ABOUT THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ASTRA TECH DENTAL IMPLANT SIZE 3 DENTAL IMPLANT JUST RELEASED ON MARKET JUNE 2008 DZE ASTRA TECH 55957
    1 ASTRA TECH DENTAL IMPLANT SIZE 3 DENTAL IMPLANT JUST RELEASED ON MARKET JUNE 2008 DZE ASTRA TECH 55957

    Patients

    Seq Age Sex Outcome Treatment
    0 46 YR Required Intervention
    1 46 YR Required Intervention