BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7, 10, MTXF, MG,HA

    MDR report key: 12387981 · Received August 30, 2021

    Report

    Report Number
    0002023141-2021-02359
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    May 5, 2021
    Report Date
    August 30, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344341
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. 510K: K133339. 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 (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

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 14 FAILED TO INTEGRATE AT THE IMPLANT SITE AND WAS REMOVED DUE TO LOW BONE DENSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280953 IMP, TSV, 4.7, 10, MTXF, MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWH10 1240817 00889024344341

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention