BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 18267447 · Received December 5, 2023

    Report

    Report Number
    0002023141-2023-03510
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    October 15, 2023
    Report Date
    December 4, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K072089
    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). D10: CONCOMITANT MEDICAL PRODUCT AND THERAPY DATES TSVB11, IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM, LOT NUMBER: 1241483. E1: REPORTER EMAIL ADDRESS UNKNOWN / NOT PROVIDED. H6: EVENT PROBLEM CODES - PATIENT CODE 1932: INFLAMMATION, 1994: PAIN. 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 A PERI-IMPLANTITIS AROUND TOOTH 35 AND 36. BOTH IMPLANTS WERE REMOVED. PATIENT SUFFERED AN EDEMA, PAIN, IMPLANT MOBILITY AND INFLAMMATION .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177750 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL 62541746

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female DENTAL IMPLANT