BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.1MM,10M

    MDR report key: 18759450 · Received February 22, 2024

    Report

    Report Number
    0002023141-2024-00431
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    January 16, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019621
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER CMP-(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D4: ADDITIONAL DEVICE INFORMATION D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H4: DEVICE MANUFACTURER DATE H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ZIMVIE RECEIVED ONE (1) TSVM4B10, (IMP,TSV,MCOL MG,4.1MM,10M) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT MATCHED THE REPORT. THE TAMPER SEAL WAS BROKEN. THE COOB IS NON-VERIFIABLE AS THE CONDITIONS OF THE PRODUCT / PACKAGING WHEN DELIVERED TO THE CUSTOMER ARE UNKNOWN. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242071. 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 1242071 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : PACKAGING : INCORRECT COMPONENT QUANTITY. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED WAS IMPROPER HANDLING OF PRODUCT OUTSIDE OF ZIMVIE CONTROLS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. THE IMPLANTS TAMPER SEAL WAS BROKEN. THE REPORTED EVENT/COOB WAS NON-VERIFIABLE SINCE THE CONDITION OF THE PRODUCT/PACKAGING 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 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER CMP (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED AN EMPTY BOX WITHOUT IMPLANT. SURGEON COMPLETED PROCEDURE WITH A DIFFERENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63989 IMP,TSV,MCOL MG,4.1MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL 1242071 00889024019621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose