BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT,TM, MTXA FULL

    MDR report key: 10651445 · Received October 8, 2020

    Report

    Report Number
    0002023141-2020-01589
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    March 17, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018969
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBERS ARE K113753 AND K112160. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR LACK OF PRIMARY STABILITY EVENTS THAT DO NOT ALLEGE A DEFICIENCY WITH THE IMPLANT AND IDENTIFIED THAT THE REPORTED EVENT IS LIKELY DUE TO BIOLOGICAL FACTORS WHICH HAVE AN ADVERSE EFFECT ON IMPLANT STABILITY OR IS RELATED TO SURGICAL TECHNIQUE AND INSERTION TORQUE. DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN/ NON-MANUFACTURING RELATED), IDENTIFYING A DEFINITIVE ROOT CAUSE IS GENERALLY NOT POSSIBLE. 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

    DR. INDICATED PRIMARY STABILITY NOT ACHIEVED AT PLACEMENT OF THE TMT6B10 IMPLANT. TOOTH SITE #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114245 IMPLANT,TM, MTXA FULL DENTAL IMPLANT DZE ZIMMER DENTAL TMT6B10 1227657 00889024018969

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention