BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTERYFIT IMPLANT

    MDR report key: 19971657 · Received August 13, 2024

    Report

    Report Number
    3011390931-2024-00591
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    March 3, 2024
    Report Date
    August 13, 2024
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108817119
    PMA / PMN Number
    K140440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN COMPLETED, EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF MISSING EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING IMPLANTATION DATE. THE DHR WAS REVIEWED FOR LOT#9000798, AND NO EVIDENCE WAS DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTS THAT NMAF4220, LOT#9000798 IMPLANT WAS REMOVED AT (B)(6) 2024. THE IMPLANTATION DATE HAS NOT BEEN PROVIDED. OBSERVED DURING THE EVENT: MOBILITY, PAIN. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894508 PTERYFIT IMPLANT PTERYFIT DENTAL IMPLANT DZE NORIS MEDICAL LTD NMAF4220 9000798 07290108817119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown