BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 14699642 · Received June 15, 2022

    Report

    Report Number
    0002023141-2022-01520
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    April 28, 2022
    Report Date
    December 5, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4), PATIENT WEIGHT NOT PROVIDED, ADDITIONAL 510(K) NUMBER IS K101880.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H4: DEVICE MANUFACTURER DATE. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT BECAME FRACTURED AND WAS REMOVED. TOOTH #14.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847313 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB10 1221160 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention