BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 19482709 · Received June 7, 2024

    Report

    Report Number
    0002023141-2024-01878
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 6, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS TSV4B10, IMP,TSV,4.1MM,SBM,10 LOT 1231105 AND TSVB10, IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM LOT 1233338. H6: EVENT PROBLEM CODES ¿ PATIENT CODE: 1690 ABSCESS, 2330 DISCOMFORT, 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

    THE PATIENT ATTENDED MOBILITY AND DISCOMFORT IN THE PROSTHETIC RESTORATION. AN X-RAY WAS TAKEN WHICH SHOWED BONE LOSS IN THE ENTIRE PERI-IMPLANT AREA AND WAS REMOVED. PROCEDURE NOT COMPLETED. PATIENT PRESENTED ABSCESS, PAIN AND INFLAMMATION. TOOTH SITE 16, 25 AND 23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100561 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL 1231105 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male DENTAL IMPLANT.