BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    MDR report key: 19013613 · Received April 1, 2024

    Report

    Report Number
    0002023141-2024-01007
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    June 18, 2023
    Report Date
    March 31, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017177
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D10: CONCOMITANT MEDICAL PRODUCT AND THERAPY DATES: TSVWB10, IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM, LOT NUMBER: 1242899. G4: PREMARKET IDENTIFICATION: K011245/K002188. 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. H3 OTHER TEXT : SUMMARY INVESTIGATION.

    Description of Event or Problem · 0

    THE DOCTOR SUSPECTED THAT THE PATIENT'S SEVERE DIABETES IS THE CAUSE OF THE LOSS OF IMPLANTS. IMPLANTS 32 AND 34 WERE INFECTED AND WERE REMOVED DUE TO PERI IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518387 IMPL TAPERED SP 3.7MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 2018021422 00889024017177

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female