BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.1MM MTX FULL,13M

    MDR report key: 12860602 · Received November 23, 2021

    Report

    Report Number
    0002023141-2021-03368
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    June 30, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018952
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K113753/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 · 0

    IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS UNABLE TO BE PLACED AND WAS REMOVED. SURGERY WAS COMPLETED USING ANOTHER IMPLANT. TOOTH LOCATION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760693 IMP TM 4.1MM MTX FULL,13M DENTAL IMPLANT DZE ZIMMER DENTAL TMT4B13 1234592 00889024018952

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention