BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 8738857 · Received June 27, 2019

    Report

    Report Number
    0002023141-2019-00346
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    February 18, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT (B)(4) WAS A DUPLICATE COMPLAINT OF (B)(4). NO FURTHER MEDWATCH REPORTS WILL BE SUBMITTED UNDER THIS MFR NUMBER (0002023141-2019 -00345).

    Description of Event or Problem · 0

    THIS COMPLAINT (B)(4) WAS A DUPLICATE COMPLAINT OF (B)(4).

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT'S WEIGHT NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBERS: K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FRACTURED IMPLANT (TSVB10) WAS FOUND DURING AN EXAM. THE IMPLANT WAS REMOVED AND THE PATIENT WILL RETURN IN 3-4 MONTHS TO HAVE THE IMPLANT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533744 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 63494386

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention