BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 7481590 · Received May 2, 2018

    Report

    Report Number
    0001038806-2018-00497
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    March 27, 2018
    Report Date
    August 24, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW VENT IMPLANT PACKAGE WAS RETURNED FOR INSPECTION WITH THE IMPLANT. VISUAL INSPECTION CONFIRMED THAT THE VIAL CAP WAS MISSING. THE IMPLANT SHOWS SIGNS OF USE, AS IT IS SLIGHTLY WORN AND CONTAINS DEBRIS SIMILAR TO TISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED AND ONE (1) RELATED NON-CONFORMANCE WAS FOUND FOR THIS LOT. IT STATES THAT ONE OF THE ITEMS WAS FOUND TO HAVE THE CAP ALREADY CRACKED. ALTHOUGH THIS IS RELATED TO THE STATE THE CUSTOMER REPORTS THE VIAL WAS IN UPON OPENING, INFORMATION REGARDING THE VIAL CAP COULD NOT BE VERIFIED, AS THE CAP WAS NOT RETURNED FOR INSPECTION. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT, ADVENT AND TRABECULAR METAL IMPLANTS¿ 4869 REV 7-01/16. 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. COMPLAINT INDICATES THE IMPLANT PACKAGING WAS ALREADY OPENED, AND THAT DIRT WAS FOUND ON THE TOP OF THE INNER VIAL ALLEGED EVENT IS NON-VERIFIABLE, AS THE PACKAGE WAS RETURNED ALREADY OPENED. NO SIGNS OF DEBRIS WERE FOUND ON THE PACKAGING. DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO¿ TO ¿YES¿.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL DEVICE 510K NUMBER K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR TOOK THE BOX FROM HIS STOCK AND DID NOT NOTICE ANYTHING UNUSUAL WITH THE BOX, BUT WHEN HE OPENED THE OUTER VIAL, IT APPEARED LIKE IT WAS ALREADY OPENED, AND NOTICED DIRT ON TOP OF INNER VIAL (TSVWB10). IT WAS ALSO REPORTED THAT DOCTOR PLACED ANOTHER IMPLANT FROM THE STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322671 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM IMPLANT DZE ZIMMER DENTAL 63325685

    Patients

    Seq Age Sex Outcome Treatment
    1