BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 12710275 · Received October 28, 2021

    Report

    Report Number
    0002023141-2021-03023
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    September 5, 2021
    Report Date
    December 20, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019829
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL SUBMISSION 0002023141 - 2021 - 03023 ¿ 3 HAS BEEN SUBMITTED TO CORRECT SECTION H1 TYPE OF REPORTED EVENT OF SUPPLEMENTAL 0002023141 - 2021 - 03023 ¿ 1, WHICH INDICATED THAT THE REPORTED EVENT IS A DEATH. IN THIS CASE, THE EVENT DID NOT RESULT IN A DEATH BUT SHOULD HAVE INDICATED SERIOUS INJURY AS INITIALLY SPECIFIED WITHIN 0002023141-2021-03023.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D1: BRAND NAME. D4: CATALOG. D4: UDI AND LOT NUMBER UNKNOWN / NOT PROVIDED. D4: EXPIRATION DATE. D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES'. G3: DATE RECEIVED BY MANUFACTURER. G4: PMA/510(K) NUMBER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H4: DEVICE MANUFACTURE DATE. H10: ADDITIONAL NARRATIVE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT OR PROBLEM.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). FIRST/GIVEN NAME: UNKNOWN / NOT PROVIDED. 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

    DOCTOR REPORTED PERI-IMPLANTITIS. PROVISIONAL PROSTHESIS WAS PLACED AND REMOVED AFTER 6 MONTHS. PATIENT WOULD BE RESCHEDULED FOR NEW IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612306 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B10 1239954 00889024019829

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention