BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0009613348-2024-012605

    MDR report key: 20282310 · Received September 23, 2024

    Report

    Report Number
    0009613348-2024-012605
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 23, 2024
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    PMA / PMN Number
    K121131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (PATIENOR 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 THE PATIENT'S MOUTH, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671011 DZE INSTITUT STRAUMANN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention