BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7, 13, MTXF, MG,HA

    MDR report key: 10285680 · Received July 16, 2020

    Report

    Report Number
    0002023141-2020-01068
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    February 15, 2020
    Report Date
    July 16, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344365
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. ADDITIONAL PMA/510(K) 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 (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 IMPLANT (TSVTWH13 ) WAS UNABLE TO BE PLACED. IMPLANT LACK OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 5. SITE WAS BONE GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745602 IMP, TSV, 4.7, 13, MTXF, MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWH13 1226188 00889024344365

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention