BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 7646893 · Received June 28, 2018

    Report

    Report Number
    0001038806-2018-00662
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    April 24, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THAT INFORMATION WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT MFR NUMBER. THERE WILL BE NO FURTHER SUPPLEMENTAL REPORTS SUBMITTED UNDER THIS NUMBER. THIS EVENT WILL BE REPORTED ON MFR-0002023141-2018-00867.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPRESSION POST WOULD NOT COME OFF THE IMPLANT WHEN THE DENTIST WAS PLACING THE IMPLANT. IMPLANT WAS REMOVED AND ANOTHER ONE WAS PLACED. TOOTH LOCATION #6.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS NOT BEEN RETURNED. ADDITIONAL 510K CODES: K101880. PRODUCT NO RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPRESSION POST WOULD NOT COME OFF THE IMPLANT WHEN THE DENTIST WAS PLACING THE IMPLANT. IMPLANT WAS REMOVED AND ANOTHER ONE WAS PLACED. TOOTH LOCATION #6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489588 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 63694747

    Patients

    Seq Age Sex Outcome Treatment
    1