BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,DUAL SEL,HA

    MDR report key: 16640969 · Received March 29, 2023

    Report

    Report Number
    0002023141-2023-00940
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    February 10, 2023
    Report Date
    September 4, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019348
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) EMPTY PACKAGING FOR A TSV4H8, (IMP,TSV,4.1MM,DUAL SEL,HA) FOR EVALUATION. VISUAL EVALUATION IDENTIFIED THE OUTER BOX WITH OUTER VIAL RETURNED. IMPLANT INNER VIAL WAS EMPTY WITH SEAL BROKEN. NO IMPLANT RETURNED. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1252593. 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 1252593 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. APPROPRIATE DOCUMENTS WERE REVIEWED. INFORMATION IDENTIFIED: 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 INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00257-PFMEA REV.2, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS IMPROPER HANDLING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A PACKAGING MALFUNCTION COULD NOT BE VERIFIED, AND THE REPORTED EVENT/COOB WAS NON-VERIFIABLE SINCE THE CONDITION OF THE PRODUCT/PACKAGING WHEN RECEIVED BY THE CUSTOMER WAS UNKNOWN. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED.. PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT AT THE TIME OF THE INTERVENTION, HE REALIZED THAT THE IMPLANTS WERE NOT INSIDE THE IMPLANT CONTAINER. THE AFFECTED DENTAL POSITIONS ARE UNKNOWN. THE DOCTOR CONFIRMS IN THE PER THAT THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER 2 IMPLANTS.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT AT THE TIME OF THE INTERVENTION, HE REALIZED THAT THE IMPLANTS WERE NOT INSIDE THE IMPLANT CONTAINER. THE AFFECTED DENTAL POSITIONS ARE UNKNOWN.THE DOCTOR CONFIRMS IN THE PER THAT THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER 2 IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591274 IMP,TSV,4.1MM,DUAL SEL,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSV4H8 1252593 00889024019348

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose