BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12923470 · Received December 3, 2021

    Report

    Report Number
    0002023141-2021-03471
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Report Date
    May 23, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019560
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) ONE (1) IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM (TSVH10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT RETURNED WITH ORIGINAL PACKAGING ATTACHED TO THE BUNDLED MOUNT OUTSIDE OF THE BROKEN STERILE BARRIER. SIGNS OF USE/BONE RESIDUE WAS OBSERVED ON THE IMPLANT THREADS. NO APPARENT MALFUNCTION IDENTIFIED WITH RETURNED DEVICE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243998). 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 (1243998) FOR SIMILAR EVENT USING KEYWORD INCORRECT COMPONENT QUANTITY AND NO OTHER COMPLAINT WAS IDENTIFIED. KEYWORDS: INCORRECT COMPONENT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT CONTAINER IS EMPTY. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS CONCLUDED WITH ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824362 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVH10 1243998 00889024019560

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown