BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12208506 · Received July 22, 2021

    Report

    Report Number
    0002023141-2021-01871
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Report Date
    December 7, 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

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. A IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. THE PACKAGE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PACKAGING IDENTIFIED LABELS/STICKERS ON THE BOX AND VIAL PLACED AS MANUFACTURED. THE OUTER VIAL IS NOTED TO BE OPENED, AND THE INNER VIAL AND ITS COMPONENTS ARE MISSING. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (1230016). 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 (1230016) FOR SIMILAR EVENT AND ONE OTHER RELEVANT COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: 'MISSING COMPONENTS' AND 'INCORRECT COMPONENT QUANTITY'. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. 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

    ZIMMER BIOMET COMPLAINT NUMBER CMP-(B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR OPENED THE PACKAGE THERE WAS NO IMPLANT IN THE INNER BOX. LABELS ALSO WERE IN THE BOX. DOCTOR PLACED OTHER IMPLANT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105400 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1230016 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown