BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM

    MDR report key: 13591664 · Received February 24, 2022

    Report

    Report Number
    0002023141-2022-00501
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 4, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510(K) NUMBER IS K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510(K) NUMBER IS K013227.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL AND CORRECTED INFORMATION. FURTHER INVESTIGATION HAS REVEALED THAT THIS EVENT DOES NO LONGER MEET THE REQUIREMENTS FOR A REPORTABLE EVENT. THE EVENT WAS INCORRECTLY REPORTED IN TO BE A SINUS PERFORATION. CUSTOMER HAS CONFIRMED THAT THIS IS A LOSS OF INTEGRATION WITH BONE LOSS. NO FURTHER MEDWATCH REPORT WILL BE SUBMITTED FOR THIS EVENT. THE FOLLOWING SECTIONS ARE BEING REPORTED:

    Description of Event or Problem · 0

    HEAVY GRANULATION TISSUE, BLEW OUT FLOOR TO SINUS, IMPLANT WAS REMOVED DUE TO LACK OF INTEGRATION AND STABILITY ISSUES. GRAFTING WAS RE-DONE WITH ALLOGRAFT, SITE SEALED AND WAITING 3 MONTHS BEFORE UNCOVERING TO PLACE IMPLANT ONCE BONE IS INTEGRATED. TOOTH SITE #27.

    Description of Event or Problem · 0

    HEAVY GRANULATION TISSUE, BLEW OUT FLOOR TO SINUS, IMPLANT WAS REMOVED DUE TO LACK OF INTEGRATION AND STABILITY ISSUES. GRAFTING WAS RE-DONE WITH ALLOGRAFT, SITE SEALED AND WAITING 3 MONTHS BEFORE UNCOVERING TO PLACE IMPLANT ONCE BONE IS INTEGRATED. TOOTH SITE #27.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONFIRMS THAT THIS EVENT IS A LOSS OF INTEGRATION WITH BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079869 IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 61243858

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention