BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 5.2 MMD X 8 MML X 4.5 MMP

    MDR report key: 14312304 · Received May 6, 2022

    Report

    Report Number
    3011649314-2022-00242
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    February 14, 2022
    Report Date
    November 5, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6101639 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. STOCK PRODUCT REVIEWED RESULTS: THE PACKAGED STOCK PRODUCT IS NOT APPLICABLE FOR REVIEW SINCE NO DEFECT WAS OBSERVED FROM THE RETURNED PRODUCT. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE DEVICE WAS VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 5.2 MMD X 8 MML X 4.5 MMP (70-1154-IMP0015) USING RADIOGRAPHIC TEMPLATE (GD-437-091015). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. SIGNIFICANT BONE DEBRIS WAS OBSERVED ON THE IMPLANT. ROOT CAUSE: "LACK OF PRIMARY STABILITY" IS A COMMON COMPLAINT IN REGARDS TO IMPLANT FAILURE. THIS OCCURS WHEN THE PATIENT'S BONE DOES NOT INTEGRATE WITH THE IMPLANT SURFACE. THE POSSIBLE RESPONSES TO THIS COMPLAINT COULD BE ATTRIBUTED TO VARIOUS CAUSES. ALTHOUGH THE ROOT CAUSE FOR LACK OF PRIMARY STABILITY IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES COULD BE 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. PREMATURE LOADING, PATIENT'S HEALTH, PERI-IMPLANTITIS, SMOKING, AND LACK OF ORAL HYGIENE MAY ALSO BE CONTRIBUTING FACTORS. IFU 3023579 REV 4.0 (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 WARNING SECTION: THE IMPLANT SITE SHOULD BE INSPECTED FOR ADEQUATE BONE BY RADIOGRAPHS, PALPATIONS AND VISUAL EXAMINATION. DETERMINE THE LOCATION OF NERVES AND OTHER VITAL STRUCTURES AND THEIR PROXIMITY TO THE IMPLANT SITE BEFORE ANY DRILLING TO AVOID POTENTIAL INJURY, SUCH AS PERMANENT NUMBNESS TO THE LOWER LIP AND CHIN. ALSO, IFU 3023579 REV 4.0 (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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: H6 (HEALTH EFFECT - CLINICAL CODE, AND TYPE OF INVESTIGATION CODES) CORRECTED DATA: H6 (MEDICAL DEVICE PROBLEM CODE). CAPA: CA-00016. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III AND THEIR ORAL HYGIENE IS NOTED AS GOOD. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2021 FOR A PRIMARY PROCEDURE ON TOOTH #14. THE PATIENT RETURNED ON (B)(6) 2022 WITHOUT COMPLAINTS. UPON EXAMINATION THE PROVIDER NOTES GRANULATION/FIBROUS TISSUE AROUND THE IMPLANT. THE DEVICE FAILED TO INTEGRATE AND THE DEVICE WAS REMOVED. BASED ON THE DATES NOTED IN THE QUESTIONNAIRE COMPLETED BY THE PROVIDER, MEDICAL OPINION WAS SOUGHT AND IT WAS DETERMINED BECAUSE THE IMPLANT WAS PLACED AND REMOVED IN SUCH A SHORT TIME SPAN THE IMPLANT LACKED STABILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III AND THEIR ORAL HYGIENE IS NOTED AS FAIR. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2021 FOR A PRIMARY PROCEDURE ON TOOTH #14. THE PATIENT RETURNED ON (B)(6) 2022 WITHOUT COMPLAINTS. UPON EXAMINATION THE PROVIDER NOTES GRANULATION/FIBROUS TISSUE AROUND THE IMPLANT. THE DEVICE FAILED TO INTEGRATE, AND THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098877 INCLUSIVE TAPERED IMPLANT 5.2 MMD X 8 MML X 4.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0015 6101639

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention