BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 11250115 · Received January 29, 2021

    Report

    Report Number
    0002023141-2021-00206
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    December 3, 2020
    Report Date
    June 9, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(6) THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ONE IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) AND ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) PACKAGING WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT BOTH IMPLANT VIALS AND BOXES ARE ALREADY OPENED. NEITHER CONTAIN COMPONENTS OR SUBCOMPONENTS. THE DEVICES ARE NOT NOTED TO BE USED IN PATIENTS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1220625. 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. ALL INSPECTED PACKAGING WAS NOTED TO CONTAIN ALL COMPONENTS AND SUBCOMPONENTS ON THE BILL OF MATERIALS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1220625) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, WHILE OPENING THE IMPLANTS ( THE INNER BOX ) FOUND OUT THAT IT WAS EMPTY AND THERE WERE NO IMPLANT IN IT. PROCEDURE COMPLETED WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151543 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1220625 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1