BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TWIST MTX 3.75 MM 13 MM

    MDR report key: 11937737 · Received June 4, 2021

    Report

    Report Number
    0002023141-2021-01443
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    February 26, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER CMP-(B)(4). EXPIRATION DATE AND UDI NOT AVAILABLE. PMA/510(K) NUMBER K943604. 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 · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837675 IMPL TWIST MTX 3.75 MM 13 MM DENTAL IMPLANT DZE ZIMMER DENTAL 0208368

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention