BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 18408848 · Received December 28, 2023

    Report

    Report Number
    0002023141-2023-03640
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    June 11, 2023
    Report Date
    June 5, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION K101880.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (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) TSVTWB10, (IMP,TSV,4.7,10,MTX,MG) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. THE IMPLANT WAS FRACTURED AT THE COLLAR REGION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1222751. 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 1222751 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE LONG-TERM PARAFUNCTIONAL HABITS (E.G., CLENCHING, BRUXISM, AND OVERLOADING) OF THE PATIENT OVER THE IMPLANTATION PERIOD ¿ PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. 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.

    Description of Event or Problem · 0

    DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 16.

    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
    2273035 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1222751 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female