BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0009613348-2024-012995

    MDR report key: 20336674 · Received September 30, 2024

    Report

    Report Number
    0009613348-2024-012995
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 30, 2024
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH NUMBER COULD BE VERIFIED. 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 REMOVAL OF A DENTAL IMPLANT DURING SURGERY WITHOUT THE REPLACEMENT OF ANOTHER DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE DUE TO EITHER LACK OF PRIMARY STABILITY OF THE IMPLANT (PATIENT OR PROCEDURE RELATED). IT MAY ALSO INCLUDE THE REMOVAL OF AN IMPLANT AFTER OSSEOINTEGRATION DUE TO EITHER THE CLINICIAN'S OR PATIENT¿S DECISION. THE MANUFACTURER¿S TREND ANALYSIS CONFIRMS THAT USUALLY PROCEDURAL ERRORS AND/OR PATIENT'S CONDITION CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 8, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607372 DZE INSTITUT STRAUMANN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention