BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    MDR report key: 10982805 · Received December 10, 2020

    Report

    Report Number
    0002023141-2020-02259
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    September 10, 2020
    Report Date
    April 15, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017177
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SP 3.7MM 10M M OCTAGON (SPB10) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SOME SIGNS OF USAGE DUE TO STUCK MOUNT. FUNCTIONAL TESTING WAS PERFORMED. THE MOUNT WAS STUCK IN THE IMPLANT AND COULD NOT BE DISENGAGED. PRE-EXISTING CONDITION WAS NOTED ON THE PER WAS PATIENT WITH LOW BONE DENSITY OF TYPE III. THE IMPLANT HAD BEEN PLACED ON TOOTH #30 (UNIVERSAL) AND REMOVED THE SAME DAY. X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2019061510. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW BY LOT NUMBER (2019061510) WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    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.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA (510K) #: K011245, K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION # 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448521 IMPL TAPERED SP 3.7MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPB10 2019061510 00889024017177

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention