BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH

    MDR report key: 8712956 · Received June 19, 2019

    Report

    Report Number
    0002023141-2019-00301
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 19, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K142082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR COMPLAINTS FOR THE INABILITY TO ACHIEVE PRIMARY STABILITY (UNABLE TO PLACE IMPLANT INTO OSTEOTOMY) HAVE BEEN PREVIOUSLY INVESTIGATED. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PREVIOUSLY RETURNED PRODUCT HAVE NOT IDENTIFIED OR SUGGESTED MANUFACTURING NON-CONFORMANCES. TO DATE, ALL COMPLAINT DATA WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/IE ESCALATION. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE SUBJECT LOT (1221695) DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, THERE HAVE BEEN NO RELATED COMPLAINTS REPORTED AGAINST THE SUBJECT LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (CM3111) COULD NOT BE PLACED INTO OSTEOTOMY. IMPLANT WAS REMOVED AND SITE WAS GRAFTED. TOOTH LOCATION 13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507690 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL 1221695

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR