BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 12208377 · Received July 22, 2021

    Report

    Report Number
    0002023141-2021-01870
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 4, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. 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 MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR FROM USE AT THE IMPLANT THREADS. FUNCTIONAL TESTING NOTES THAT THE MOUNT WAS ABLE TO DISENGAGE AS NORMAL WITH STANDARD HAND TOOLS. THE DRIVE FEATURE DOES NOT SHOW SIGNS OF DAMAGE. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 45 (FDI) AND WAS REMOVED THE SAME DAY AS PLACEMENT. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: 1222652. 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 WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1222652) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED UTILIZING KEYWORD(S) DOES NOT DISENGAGE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS UNCONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER CMP-(B)(4). PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS WAS NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER K013227.

    Description of Event or Problem · 1

    THE DOCTOR REPORTS THAT HE WAS UNABLE TO REMOVE THE MOUNT AND THEREFORE HAD TO USE ANOTHER IMPLANT TO FINISH THE SURGICAL PROCEDURE. THE AFFECTED DENTAL POSITION IS 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105206 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1222652 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown