BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 6.0, 13, MTXF, MG,HA

    MDR report key: 21418655 · Received February 20, 2025

    Report

    Report Number
    0002023141-2025-00451
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 15, 2025
    Report Date
    June 10, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344266
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K133339.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVT6H13, (IMP, TSV, 6.0, 13, MTXF, MG, HA) FOR EVALUATION. VISUAL EVALUATION AND A FUNCTIONAL TEST WAS PERFORMED; THE IMPLANT WAS NOT RETURNED IN THE ORIGINAL PACKAGING. THE IMPLANT SHOWS NO SIGNS OF WEAR/USE. FUNCTIONALLY TESTED WITH RETURNED MOUNT AND SCREW AND IT ENGAGES AND DISENGAGES AS INDENTED. NO MALFUNCTION IDENTIFIED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1260389. 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 1260389 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: FUNCTIONAL: DISENGAGED¿. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED WAS LIKELY IMPROPER HANDLING OF PRODUCT OUTSIDE OF ZIMVIE CONTROLS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A PACKAGING MALFUNCTION COULD NOT BE VERIFIED. THE IMPLANT WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. HOWEVER, THE IMPLANT PERFORMED AS INTENDED DURING A FUNCTIONAL TEST. THE REPORTED EVENT WAS 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED SCREW FROM FMT5 WAS NOT SECURE WHEN REMOVING FROM PACKAGE. CAUSED IMPLANT TO DROP ON GROUND AND NO BE USEABLE. NO SYMPTOMS AS A RESULT OF THE EVENT. DOCTOR INDICATED NO IMPACT TO THE PATIENT.

    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
    1388034 IMP, TSV, 6.0, 13, MTXF, MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL 1260389 00889024344266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown