BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 14M M OCTAGON

    MDR report key: 15603043 · Received October 14, 2022

    Report

    Report Number
    0002023141-2022-02580
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    May 24, 2022
    Report Date
    February 24, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017191
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K011245 AND K002188.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANT FAILED BECAUSE IT WAS FRACTURED IN THE NECK.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273219 IMPL TAPERED SP 3.7MM 14M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPB14 63739317 00889024017191

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention