BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN XD INT. HEX. IMPLANT D3.75 L10MM SP

    MDR report key: 20220503 · Received September 15, 2024

    Report

    Report Number
    3004203816-2023-10156
    Event Type
    Injury
    Date Received
    September 15, 2024
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    UDI-DI
    07290113997721
    PMA / PMN Number
    K180282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 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 04/06/2022 - 07/28/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107117 SEVEN XD INT. HEX. IMPLANT D3.75 L10MM SP IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. NA 07290113997721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention