BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,11.5,MTX,MG

    MDR report key: 15690229 · Received October 28, 2022

    Report

    Report Number
    0002023141-2022-02711
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    July 13, 2022
    Report Date
    March 3, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019935
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). 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 NON-EXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION FOR THE INITIAL REPORT . CORRECTION: THE REPORTED TOOTH LOCATION WAS CORRECTED/UPDATED FROM #6 TO #3. THE FOLLOWING SECTIONS ARE BEING REPORTED. B4: DATE OF THIS REPORT WAS UPDATED. B5: DESCRIPTION OF EVENT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED . H2: TYPE OF FOLLOW UP WAS UPDATED. H10: ADDITIONAL NARRATIVE/DATA WAS UPDATED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION FOR THE INITIAL REPORT 0002023141-2022-02711. CORRECTION: THE REPORTED ITEM NUMBER TSVT4B10, LOT NUMBER 1250924 IS BEING CORRECTED/UPDATED TO TSVTB11, LOT #1251592.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DENTIST TORQUED THE LOCATOR ABUTMENT ON THE IMPLANT AT TOOTH SITE #6. THE IMPLANT SPUN AND LOST INTEGRATION DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED.

    Description of Event or Problem · 0

    UPON FOLLOW UP, THE TOOTH LOCATION WAS UPDATED.

    Description of Event or Problem · 0

    UPON FOLLOW UP, THE ITEM NUMBER AND LOT NUMBER WERE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704058 IMP,TSV,3.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B10 1251592 00889024019935

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention DENTAL LOCATOR ABUTMENT-SEE H10 NARRATIVE