BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 15920102 · Received December 5, 2022

    Report

    Report Number
    0002023141-2022-03019
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    October 27, 2022
    Report Date
    April 12, 2023
    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
    PR, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: DENTAL IMPLANT:TSVT6B10, LOT NUMBER: 1250935. ITEM NAME: IMP,TSV,6.0,10,MTX,MG. G4: PMA/510(K) NUMBER: K101880. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA. CORRECTED DATA: THE TYPE OF INVESTIGATION RECORD, 10 (TESTING OF ACTUAL/SUSPECTED DEVICE) WAS REPORTED IN ERROR. IT NEEDS TO BE REMOVED. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. B5: EVENT DESCRIPTION WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H6: TYPE OF INVESTIGATION RECORD WAS UPDATED. H10: NARRATIVE/DATA WAS UPDATED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW BROKE INSIDE OF THE IMPLANT AND BECAME FRACTURED ON TOOTH SITE #19. IT HAD TO BE REMOVED. A WIDER IMPLANT WAS ATTEMPTED BUT IT DIDN'T ACHIEVE PRIMARY STABILITY.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470744 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB10 1257016 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention DENTAL IMPLANT- SEE H10 NARRATIVE.