BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSV MTX FFIT TP

    MDR report key: 19123683 · Received April 17, 2024

    Report

    Report Number
    0002023141-2024-01189
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    October 5, 2023
    Report Date
    April 17, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019249
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1 PATIENT IDENTIFIER : (B)(6). A4: WEIGHT UNKNOWN / NOT PROVIDED. E1: EMAIL ADDRESS UNKNOWN / NOT PROVIDED. ZIMVIE RECEIVED ONE (1) TSV4B13, (IMP,TSV,4.1MM,SBM,13) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, BONE DEBRIS ON EXTERNAL THREADS. DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE IMPLANT WAS FRACTURED AT THE COLLAR. A FRACTURED SCREW WAS IDENTIFIED INSIDE IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230705. 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 1230705 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE IMPLANT THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV. 9-10/19. INFORMATION IDENTIFIED: BREAKAGE 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

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 7 LOST INTEGRATION AND HAS A FRACTURE. SCREW IS FRACTURED INSIDE. THE FRACTURE OCCURRED AT REMOVAL OF THE IMPLANT AND WAS BEING REMOVED DUE TO LOSS OF INTEGRATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801082 TSV MTX FFIT TP DENTAL IMPLANT DZE ZIMMER DENTAL 1230705 00889024019249

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male UNKNOWN ZIMMER SCREW.