BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C1 CONI. CON. IMPLANT D4.20 L10MM, SP

    MDR report key: 20254157 · Received September 19, 2024

    Report

    Report Number
    3004203816-2023-08024
    Event Type
    Injury
    Date Received
    September 19, 2024
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    UDI-DI
    07290108992069
    PMA / PMN Number
    K112162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BO
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS AND HARMONIZATION MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA 2304133 HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. THIS RETROSPECTIVE REVIEW COVERS THE DATE RANGE OF (B)(6) 2022 - (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506364 C1 CONI. CON. IMPLANT D4.20 L10MM, SP IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. NA 07290108992069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention