BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 17115971 · Received June 13, 2023

    Report

    Report Number
    0002023141-2023-01662
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    April 11, 2023
    Report Date
    December 17, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW VENT IMPLANT (TSV4B10), ONE RETAINING SCREW, AND ONE AH20/4 WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED FRACTURE AROUND THE IMPLANT COLLAR AND ACROSS THE SCREW THREADS. AN ABUTMENT/CROWN AND REMOVAL TOOL WERE ALSO RETURNED BUT THERE WERE NO ALLEGATIONS AGAINST THEM. NOTE: THIS INVESTIGATION ADDRESSES THE IMPLANT (TSV4B10). DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1250078) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QUALITY ASSURANCE. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1250078) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. COMPLAINT CATEGORY KEYWORD: FRACTURE: IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED IS CUSTOMER ERROR OR PATIENT FACTOR (LONG-TERM PARAFUNCTIONAL HABIT (E.G., CLENCHING, BRUXISM, AND OVERLOADING) OF THE PATIENT OVER THE IMPLANTATION PERIOD). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED. 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 FRACTURE OF THE IMPLANT COLLAR AND FRACTURE OF THE ABUTMENT SCREW, WHICH CAUSED THE CROWN TO FALL. PROCEDURE COMPLETED 36.

    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
    1988484 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL 1250078 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Prefer Not To Disclose Required Intervention