BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7579710 · Received June 7, 2018

    Report

    Report Number
    0002023141-2018-00022
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 16, 2018
    Report Date
    October 31, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TAPERED SCREW VENT IMPLANT PACKAGE WERE RETURNED FOR INSPECTION. VISUAL INSPECTION REVEALED THAT THE DEVICE PACKAGE WERE ALREADY OPENED. IMPLANT WAS RETURNED. NO RELATED NONCONFORMANCE WERE NOTED FOR THIS COMPLAINT AFTER DHR REVIEW. REVIEW OF APPROPRIATE DOCUMENTATION - INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT, ADVENT AND TRABECULAR METAL IMPLANTS 4869 REV 7-01/16. INFORMATION IDENTIFIED: PRODUCT PACKAGING. ALL IMPLANTS HAVE BEEN CLEANED, PACKAGED IN DOUBLE VIALS WITHIN AN ENVIRONMENTALLY CONTROLLED ROOM, AND STERILIZED FOR CONVENIENCE AND IMMEDIATE USE. THE IMPLANTS ARE SUSPENDED ON A CARRIER FOR TRANSFER TO THE PREPARED SURGICAL SITE WITHOUT RISK OF CONTACT CONTAMINATION. BOTH THE IMPLANT AND THE INNER VIAL PACKAGING ARE STERILE. THE LABEL ON THE OUTER VIAL PACKAGING FOR EACH IMPLANT CONTAINS A LOT NUMBER THAT SHOULD BE RECORDED IN THE PATIENT¿S FILE TO ENSURE COMPLETE TRACEABILITY OF THE PRODUCT. A PATIENT CHART LABEL PROVIDED CONTAINING THE LOT NUMBER CAN ALSO BE PLACED IN THE PATIENT FILE FOR TRACEABILITY. THE VIAL WAS FOUND WITH THE SEAL BROKEN, AND IT CANNOT BE CONFIRMED IF THESE WERE THE CIRCUMSTANCES THE PACKAGING WAS RECEIVED BY THE CUSTOMER. THE COMPLAINT IS THEREFORE NON-VERIFIABLE WITH THE INFORMATION PROVIDED. UDI: (B)(4). EVENT AND TYPE OF REPORTABLE EVENT WERE RE-ENTERED SINCE THESE FIELDS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GREEN SEALED CAP ON THE INNER PACKAGING OF THE IMPLANT (TSVB10) WAS DAMAGED. THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBERS ARE K061410, K011028, K013227. ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREEN SEALED CAP ON THE INNER PACKAGING OF THE IMPLANT (TSVB10) WAS DAMAGED. THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422361 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 63204726

    Patients

    Seq Age Sex Outcome Treatment
    1