BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.1MM,13M

    MDR report key: 7695585 · Received July 17, 2018

    Report

    Report Number
    0002023141-2018-00626
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 20, 2018
    Report Date
    November 7, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OUTER VIAL FOR A TSVM4B13 IMPLANT WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE INNER VIAL ALONG WITH THE IMPLANT WERE MISSING. THE TAMPER EVIDENT RING AT THE BOTTOM OF THE CAP WAS BROKEN. 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. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: ZIMMER DENTAL: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT, ADVENT AND TRABECULAR METAL IMPLANTS (4869 REV 7 ¿ 01/16). STERILITY: ALL IMPLANTS HAVE BEEN GAMMA RADIATION STERILIZED AND ARE FOR SINGLE USE ONLY. DO NOT RE-STERILIZE IMPLANTS. ZIMMER DENTAL PROSTHETIC AND ANCILLARY COMPONENTS ARE SOLD STERILE OR NON-STERILE. REFER TO THE SPECIFIC PACKAGING FOR VERIFICATION OF STERILITY. STERILIZE NON-STERILE PRODUCT PRIOR TO USE IN PATIENTS. SOME ZIMMER DENTAL PRODUCTS THAT ARE SOLD STERILE ARE FOR SINGLE USE ONLY; REFER TO SPECIFIC PACKAGING FOR SINGLE USE ONLY DESIGNATION. SHELF LIFE: THE PRODUCT EXPIRATION DATE IS INDICATED BY THE HOURGLASS SYMBOL ON THE PRODUCT LABEL, FOLLOWED BY THE YEAR, MONTH, AND SOMETIMES DAY OF EXPIRATION. CAUTION: DO NOT USE STERILE DEVICES IF THE PACKAGING PROVIDING THE STERILE BARRIER, INCLUDING THE OUTER CAP, VIAL, TYVEK®** LID, OR TRAY HAS BEEN DAMAGED OR COMPROMISED IN ANY MANNER (I.E. CRACKED, CRUSHED, TORN OR PEELED AWAY). 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. BASED ON THE EVENT REPORTED, THERE IS NO PROBABLE CAUSE IDENTIFIED RELATED TO THE INSTRUCTIONS FOR USE OF THE DEVICE. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO UNAUTHORIZED DEVIATIONS OR NON-CONFORMANCES WHICH COULD CAUSE OR CONTRIBUTE TO THE SUBJECT EVENT WERE DOCUMENTED AS PART OF THE DHR. LOT WAS INSPECTED AND ACCEPTED BY QA. THE COMPLAINT COULD NOT BE VERIFIED, AS THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WITH THE IMPLANT LOT THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DHR REVIEW IDENTIFIED THAT THE IMPLANT IN THE VIAL WAS FULLY INTACT DURING FINAL INSPECTION. ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. THE EXACT DETAILS OF THE DEVICE CONDITION WHEN RECEIVED BY THE CUSTOMER ARE UNKNOWN. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT, MANUFACTURER, DEVICE EXPIRATION, UDI#: (B)(4). CONTACT OFFICE, MANUFACTURER'S CONTACT OFFICE, DATE RECEIVED BY MANUFACTURER, CHECKED "FOLLOW-UP", CHECKED FOLLOW-UP TYPE, CHANGED "NO" TO "YES", DATE OF MANUFACTURE, ENTERED EVALUATION CODES, ADDED MANUFACTURER NARRATIVE. THE FOLLOWING SECTION WAS CORRECTED: LABELED FOR SINGLE USE: SELECTED "YES".

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). DEVICE HAS RETURNED THE EMPTY PACKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DENTIST RECEIVED PACKAGING WITHOUT IMPLANT. DURING THE SURGERY NOTICED THAT THE DENTAL IMPLANT PACKAGING WAS UNSEALED AND THE IMPLANT WAS MISSING. ANOTHER IMPLANT HAS BEEN USED INSTEAD AND PATIENT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535774 IMP,TSV,MCOL MG,4.1MM,13M DENTAL IMPLANT DZE ZIMMER DENTAL 63216585

    Patients

    Seq Age Sex Outcome Treatment
    1