BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TWIST MTX 3.75 MM 13 MM LZ

    MDR report key: 19033907 · Received April 3, 2024

    Report

    Report Number
    0002023141-2024-01027
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    December 18, 2023
    Report Date
    April 2, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013049
    PMA / PMN Number
    K013494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D9: DEVICE AVAILABILITY UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION: K943604. H6: EVENT PROBLEM CODES - PATIENT CODE 1932: INFLAMMATION. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 43 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728435 IMPL TWIST MTX 3.75 MM 13 MM LZ DENTAL IMPLANT DZE ZIMMER DENTAL 2022010345 00889024013049

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male