BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7,10,MTX,MC,MG,HA

    MDR report key: 9591640 · Received January 15, 2020

    Report

    Report Number
    0002023141-2020-00093
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    February 12, 2019
    Report Date
    January 15, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344143
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBERS: 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) FACTORS, 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 INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY. TOOTH LOCATION 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52709 IMP, TSV, 4.7,10,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWH10 1223284 00889024344143

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention