BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT

    MDR report key: 7524579 · Received May 17, 2018

    Report

    Report Number
    3011649314-2018-00122
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    August 23, 2018
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WERE ADDED FOR SECTIONS BELOW: ADDED INCLUSIVE TAPERED IMPLANT. ADDED DENTAL IMPLANT, INCLUSIVE TAPERED IMPLANT. ADDED K121406. ADDED "THE PATIENT HISTORY OF PERIODONTAL DISEASE AND OPEN BITE." THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. DEVICE HISTORY RECORD REVIEW (DHR) COULD NOT BE CONDUCTED AS THE IMPLANT'S LOT INFORMATION WAS NOT PROVIDED. THE COMPLAINT COULD NOT BE VERIFIED AS THE CUSTOMER DID NOT RETURN THE IMPLANT FOR EVALUATION. THE PROBABLE CAUSES FOR FAILED TO OSSEOINTEGRATE COULD BE DUE TO INSUFFICIENT BONE OR POOR BONE QUALITY. THE BONE COULD BE TOO SOFT OR THE OPERATOR ERRED IN CREATING AN OSTEOTOMY BIGGER THAN THE SIZE OF THE IMPLANT DIAMETER. PREMATURE LOADING CAN ALSO BE A FACTOR. IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF PERIODONTAL DISEASE. PATIENTS WITH A HISTORY OF PERIODONTAL DISEASE OR BAD ORAL HYGIENE MAY NOT BE ABLE TO MAINTAIN CLEANLINESS AND ADEQUATE PLAQUE REMOVAL AROUND IMPLANTS. THIS MAY ENCOURAGE PERIMUCOSITIS AND PERI-IMPLANTITIS LEADING TO IMPAIRED HEALING. A WARNING PROVIDED IN THE IFU STATES, "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." PRECAUTIONS ARE ALSO PROVIDED IN THE IFU THAT STATE, "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 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 OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO." THIS EVENT WILL BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    MULTIPLE FOLLOW-UPS WERE CONDUCTED TO OBTAIN INFORMATION ON THE EVENT AND DEVICE; HOWEVER, REQUESTED INFORMATION HAVE NOT BEEN PROVIDED YET. ONCE THE EVALUATION IS COMPLETED OR NEW INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DENTAL IMPLANT FAILED TO OSSEOINTEGRATE. IT IS UNKNOWN IF THERE WAS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366071 INCLUSIVE TAPERED IMPLANT DENTAL IMPLANT, INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR