BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9779281 · Received March 3, 2020

    Report

    Report Number
    0002023141-2020-00471
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    January 27, 2020
    Report Date
    March 3, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344341
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACED IN TOOTH SITE 31. THE IMPLANT WAS REMOVED AND NO OTHER IMPLANT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245420 IMP, TSV, 4.7, 10, MTXF, MG,HA DENTAL IMPANT DZE ZIMMER DENTAL TSVTWH10 1226808 00889024344341

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention