BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 6.0,10,MTX,MC,MG,HA

    MDR report key: 12394422 · Received August 31, 2021

    Report

    Report Number
    0002023141-2021-02382
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    June 24, 2021
    Report Date
    August 31, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344044
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT: NOT PROVIDED. FAX NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: ADDITIONAL 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 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 THE IMPLANT AT TOOTH SITE # 15 LACKED PRIMARY STABILITY AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293386 IMP, TSV, 6.0,10,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVM6H10 1240316 00889024344044

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention