BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    MDR report key: 7335608 · Received March 13, 2018

    Report

    Report Number
    0001038806-2018-00210
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    January 11, 2018
    Report Date
    May 10, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SWISSPLUS® IMPLANT PACKAGE WAS RETURNED FOR INSPECTION WITH ITS CONTENTS. VISUAL INSPECTION REVEALED THAT THE OUTER BOX AND VIAL HAVE BEEN OPENED. THE RETURNED IMPLANT APPEARS TO BE UNUSED. NO INFORMATION REGARDING THE ORIGINAL PACKAGING STERILITY COULD BE VERIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT NUMBER. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR USE FOR SWISSPLUS® AND TAPERED SWISSPLUS® IMPLANTS 9967 REV 0-09/14 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. A SINGULAR CAUSE CANNOT BE IDENTIFIED. THE COMPLAINT IS NON-VERIFIABLE, AS THE CONDITIONS OF THE PACKAGING COULD NOT BE RECREATED. D4: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K NUMBERS: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER VIAL WAS OPENED (NON STERILE). ANOTHER IMPLANT WAS PLACED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178041 IMPL TAPERED SP 3.7MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 63629417

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR