BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BL, Ø 4.1MM RC, SLA® 10MM, TI, LOXIM

    MDR report key: 21003031 · Received December 23, 2024

    Report

    Report Number
    0009613348-2024-017789
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    September 12, 2024
    Report Date
    December 23, 2024
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    PMA / PMN Number
    K062129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 1. ABSENCE OF PERSISTENT SUBJECTIVE COMPLAINTS SUCH AS PAIN, FOREIGN BODY SENSATION AND /OR DYSESTHESIA 2. ABSENCE OF A RECURRENT PERI-IMPLANT INFECTION WITH SUPPURATION 3. ABSENCE OF IMPLANT MOBILITY 4. 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 · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2022 IN FDI 11. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. 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
    2616864 BL, Ø 4.1MM RC, SLA® 10MM, TI, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention