BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP

    MDR report key: 9290168 · Received November 7, 2019

    Report

    Report Number
    3011649314-2017-00526
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    September 26, 2017
    Report Date
    November 7, 2019
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENTS WEIGHT IS NOT PROVIDED AS IT IS NOT TAKEN AT THE TIME OF THE APPOINTMENT. THE PATIENT'S RACE AND ETHNICITY WERE NOT PROVIDED THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DEVICE HISTORY RECORD: THE DHR WAS REVIEWED AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. RETURNED SAMPLE: THE IMPLANT WAS RETURNED WITH A CARRIER BUT NOT IN ORIGINAL PACKAGE. THE PART WAS MEASURED AND VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 3.7 MM X 13 MM X 3.5 MM (70-1070-IMP0008). COMPLAINT INVESTIGATOR MEASURED THE CRITICAL PARAMETERS AGAINST DWG 3003642 REV 6.0 FROM DHR AND FOUND NO DEVIATION. THE IMPLANT THREAD AND INTERNAL HEX WERE INTACT. THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED. BONE DEBRIS WAS OBSERVED FROM THE IMPLANT. ROOT CAUSE: PROBABLE CAUSES COULD BE THE LOSS OF PRIMARY STABILITY AT THE OSTEOTOMY SITE DUE TO INSUFFICIENT BONE OR POOR BONE QUALITY; EITHER THE BONE WAS TOO SOFT OR THE OPERATOR ERRED IN CREATING AN OSTEOTOMY BIGGER THAN THE SIZE OF THE IMPLANT DIAMETER. IFU 3023579 REV 2.0 (INCLUSIVE DENTAL IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN WARNING SECTION: "ABSOLUTE SUCCESS CANNOT BE GUARANTEED. FACTORS SUCH AS INFECTION, DISEASE AND INADEQUATE BONE QUALITY AND/OR QUANTITY CAN RESULT IN OSSEOINTEGRATION FAILURES FOLLOWING SURGERY OR INITIAL OSSEOINTEGRATION" THE IFU ALSO CONTAINS THE FOLLOWING STATEMENT IN PRECAUTION SECTION: "MINIMIZING TISSUE DAMAGE IS CRUCIAL TO SUCCESSFUL IMPLANT OSSEOINTEGRATION. IN PARTICULAR, CARE SHOULD BE TAKEN TO ELIMINATE SOURCES OF INFECTION, CONTAMINANTS, SURGICAL AND THERMAL TRAUMA. RISK OF OSSEOINTEGRATION FAILURE INCREASES AS TISSUE TRAUMA INCREASES. ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL AND COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. IMPLANTS SHOULD BE PLACED WITH SUFFICIENT STABILITY; HOWEVER, EXCESSIVE INSERTION TORQUE MAY RESULT IN IMPLANT FRACTURE, OR FRACTURE OR NECROSIS OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT BONE GRADE WAS NOT PROVIDED. THE PATIENT HAS EDENTULOUS DENTATION BOTH UPPER AND LOWER. THE PATIENT HAS NO OTHER MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT. THE PATIENT PRESENTED ON (B)(6) 2017 FOR INITIAL IMPLANT PLACEMENT. ON (B)(6) 2017 THE PATIENT RETURNED, THE IMPLANT WAS NOT REMOVED AT THAT TIME. HOWEVER, THE PATIENT RETURNED ON (B)(6) 2017 AND UPON EXAM THE PROVIDER NOTES A LACK OF STABILITY. IT WAS AT THAT TIME THAT THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083642 INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0008 6021842

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR