BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP

    MDR report key: 8523998 · Received April 17, 2019

    Report

    Report Number
    3011649314-2019-00083
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 5, 2019
    Report Date
    July 23, 2019
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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. PROBABLE CAUSES COULD BE THE LACK 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. SMOKING IS KNOWN TO INHIBIT LOCAL WOUND HEALING AND MAY AFFECT SURVIVAL OF IMPLANTS. SMOKING HAS A STRONG INFLUENCE ON THE COMPLICATION RATES OF IMPLANTS. IT CAUSES SIGNIFICANTLY MORE MARGINAL BONE LOSS AFTER IMPLANT PLACEMENT, INCREASED THE INCIDENCE OF PERI-IMPLANTITIS (DEEP MUCOSAL POCKETS AROUND DENTAL IMPLANTS, INFLAMMATION OF THE PERI-IMPLANT MUCOSA, AND INCREASED RESORPTION OF PERI-IMPLANT BONE, AND AFFECTS THE SUCCESS RATES OF BONE GRAFTS. IFU 3023579 REV 3.0 (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." IN ADDITION, IFU 3023579 REV 3.0 (INCLUSIVE DENTAL IMPLANT SYSTEM) 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." THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    PATIENT'S ETHNICITY AND RACE WERE NOT PROVIDED; HOWEVER, IT WAS REPORTED THAT THE PATIENT'S NATIONALITY IS (B)(6). THE REPORTED DEVICE IS BEING RETURNED BY THE DISTRIBUTOR. ONCE THE DEVICE'S EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT FOR IS THE 1ST OF 2 REPORTED IMPLANTS FOR THE SAME PATIENT: REFERENCE 3011649314-2019-00084 ((B)(6)) FOR THE 2ND IMPLANT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR THE 1ST OF 2 FAILED IMPLANTS FOR THE SAME PATIENT. IT WAS REPORTED THAT AN INCLUSIVE TAPERED IMPLANT LACKED PRIMARY STABILITY. THE DOCTOR REPORTED THAT THE IMPLANT WAS PLACED IN TOOTH LOCATION #29 (UNIVERSAL) ON (B)(6) 2018. THE PATIENT'S BONE WAS WEAK, SO THE DOCTOR USED A GRAFT BEFORE IMPLANT PLACEMENT. THE PATIENT RETURNED ON (B)(6) 2019, AND THE DOCTOR NOTED THAT THERE WAS MOBILITY WITH THE IMPLANT. THEREFORE, THE DOCTOR REMOVED THE IMPLANT DUE TO LACK OF PRIMARY STABILITY. THERE WAS NO PAIN OR INFECTION REPORTED. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE FINE. THE PATIENT HAS TYPE II BONE, AND HAS A HISTORY OF SMOKING. THERE WAS NO ABNORMALITY NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315819 INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0006 6041204

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR