BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,3.7,13,MTX,MG

    MDR report key: 15853955 · Received November 23, 2022

    Report

    Report Number
    0002023141-2022-02933
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    April 1, 2022
    Report Date
    March 23, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019942
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4), THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: EXPIRATION DATE. D4: UDI NOT AVAILABLE. D9: DEVICE AVAILABLE FOR EVALUATION CHANGE "NO" TO "YES". G3: DATE RECEIVED BY THE MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE "NO: TO "YES". H4: DEVICE MANUFACTURE DATE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE PACKING FOR A TAPERED SCREW VENT IMPLANT (TSVTB13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PACKAGING IDENTIFIED THAT IT WAS ALREADY OPENED BY THE CUSTOMER AND THE VIAL CAP STERILE BARRIER WAS BROKEN. THE IMPLANT WAS RETURNED IN A SEPARATE BAG. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. PATIENT PRE-EXISTING CONDITIONS, TOOTH LOCATION, PLACEMENT DURATION AND X-RAY IMAGE WERE IRRELEVANT TO THIS INVESTIGATION. PICTURE EVALUATION: NO PICTURE PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS, IFU4869 REV 9 - 10/19. INFORMATION IDENTIFIED: PRODUCT PACKAGING. PER THE APPLICABLE IFU, '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'. DHR REVIEW: DHR REVIEW FOR THE LOT (1223374¿ IMPLANT LOT) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1223374¿ IMPLANT LOT) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORD: DENTAL: NON-STERILE PRODUCT; PACKAGING: INCORRECT COMPONENT QUANTITY) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE REPORTED MALFUNCTION DID OCCUR. HOWEVER, THE REPORTED EVENT/COOB COULD NOT BE VERIFIED SINCE OPEN PACKAGING WAS RETURNED AND VIAL CAP STERILE BARRIER WAS IDENTIFIED TO BE BROKEN ¿ CONDITIONS OF USE OUTSIDE OF ZIMVIE CONTROLS ARE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY, AT THE TIME OF UNPACKING THE PRODUCT, IT WAS NOTED THAT THE IMPLANT CONTAINER COMES OPEN WITH THE IMPLANT INSIDE, ANOTHER IMPLANT WAS USED TO COMPLETE THE DENTAL PROCEDURE.

    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
    291821 IMP,TSV,3.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB13 1223374 00889024019942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown