BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 851273 · Received May 3, 2007

    Report

    Report Number
    3005503242-2007-00006
    Event Type
    Other
    Date Received
    May 3, 2007
    Date of Event
    January 1, 2006
    Report Date
    May 23, 2006
    Manufacturer
    BIOMEDICARE, INC.
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS NOT INITIALLY INVESTIGATED. COMPLAINT PROCEDURE RECENTLY REVISED TO REQUIRE APPROPRIATE INVESTIGATION AND REPORTING OF EVENTS. REPORT BEING SUBMITTED SUBSEQUENT TO COMPLETION OF INVESTIGATION. TYPE OF TEST(S): SEND THE RETURNED PRODUCT TO THE LAB FOR SEM (SCANNING ELECTRON MICROSCOPE) IMAGING TO VERIFY SLA (SAND BLASTING WITH LARGE GRIT ACID ETCHING) TYPE SURFACE TREATMENT WAS COMPLETED. RE-INSPECT THE RETURNED PRODUCT'S DIMENSIONS TO VERIFY IF THE PRODUCT MEETS ITS SPECIFICATIONS. RESULTS: SEE ATTACHED TEST DATA. AS A RESULT OF A SEM IMAGING, SLA TYPE SURFACE TREATMENT WAS COMPLETED. AS A RESULT OF A RE-INSPECTION, THE PRODUCT MEETS ITS SPECIFICATIONS. CONCLUSION: BASED ON INSPECTION AND TEST RESULTS, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PATIENT BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT BEHAVIOR.

    Description of Event or Problem · 1

    INITIAL REPORT WAS SIZE ERROR. ON INVESTIGATION, DENTIST SUBSEQUENTLY STATED THAT PATIENT'S BONE WAS TOO SOFT RESULTING TWO FAILED IMPLANTS. PATIENT RECEIVED A THIRD IMPLANT THAT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE BIOMEDICARE, INC. FX4810 05I21-D

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention