BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 19341697 · Received May 17, 2024

    Report

    Report Number
    0002023141-2024-01652
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020030
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED A3: GENDER UNKNOWN / NOT PROVIDED A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED B3: DATE OF EVENT UNKNOWN / NOT PROVIDED

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVTWB8, (IMP,TSV,4.7,8,MTX,MG) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED PACKAGING / VIALS IDENTIFIED ONLY THE IMPLANT'S MOUNT WAS RETURNED. THE RETURNED IMPLANT PACKAGING WAS EMPTY. THE OUTER VIAL WAS OPENED, AND THE TAMPER SEAL / RING WAS BROKEN. THE INNER VIAL WAS ALSO EMPTY, AND WHAT APPEARS TO BE DRIED BLOOD CAN BE SEEN ATTACHED TO THE EXTERIOR OF THE INNER VIAL. ONE MOUNT WAS RETURNED INSIDE AN AUTOCLAVE BAG WITH NO SIGNS OF USE, OR APPARENT MALFUNCTION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENTS COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENTS. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1251904. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1251904 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿INCORRECT COMPONENT QUANTITY¿ & "FOREIGN MATTER". THE CUSTOMER DID SUBMIT ONE (1) IMAGE FOR THE REPORTED EVENTS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00308-PFMEA REV.1, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS IMPROPER HANDLING OF DEVICES/PACKAGING OUTSIDE OF ZIMVIE CONTROL. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED. THE REPORTED EVENT/COOB WAS NON-VERIFIABLE SINCE THE CONDITION OF THE PRODUCT/PACKAGING WHEN RECEIVED BY THE CUSTOMER IS UNKNOWN / NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT PACKAGING WAS RECEIVED WITH NO IMPLANT AND RUST/BLOOD STAIN INSIDE PACKAGING. DISCOVERED DURING PROCEDURE, BUT THEY WERE ABLE TO COMPLETE IT WITH A DIFFERENT IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921656 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1251904 00889024020030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose