BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP 4.1MM RN, SLA 10MM, TIZR, NTP

    MDR report key: 12326293 · Received August 16, 2021

    Report

    Report Number
    0009613348-2021-60114
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 16, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031718754
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH NUMBER COULD NOT BE VERIFIED DUE TO INCOMPLETE OR MISSING INFORMATION AND / OR PRODUCT FROM THE CUSTOMER. OUR MANUFACTURING Q-SYSTEM ASSURES THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFIRM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED. THE LOSS OF AN ENDOSSEOUS DENTAL IMPLANT AFTER SUCCESSFUL OSSEOINTEGRATION AND RESTORATION IS A KNOWN INHERENT RISK OF THE PROCEDURE. IMPLANTS MAY HAVE TO BE REMOVED IN CASE ONE OR MORE OF THE IMPLANT SUCCESS CRITERIA ARE NOT MET. IMPLANT SUCCESS CRITERIA ACCORDING TO BUSER ET AL. (1991) ARE: ABSENCE OF PERSISTENT SUBJECTIVE COMPLAINTS SUCH AS PAIN, FOREIGN BODY SENSATION AND /OR DYSESTHESIA. ABSENCE OF A RECURRENT PERI-IMPLANT INFECTION WITH SUPPURATION. ABSENCE OF IMPLANT MOBILITY. ABSENCE OF A CONTINUOUS RADIOLUCENCY AROUND THE IMPLANT. THE MANUFACTURER'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS TREATMENT AS PUBLISHED IN THE SCIENTIFIC LITERATURE.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2015 IN FDI 13. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224707 SP 4.1MM RN, SLA 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA Roxolid TL 07630031718754

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention