BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,13,MTX,MG

    MDR report key: 9459849 · Received December 12, 2019

    Report

    Report Number
    0002023141-2019-01281
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    October 28, 2019
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW-VENT IMPLANT WITH FULL MTX SURFACE TEXTURING AND MICROGROOVES (TSVTB13) WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR SIGNS OF WEAR AND BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE DHR REVIEW FOR THE LOT (1223102) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT (PAIN). ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. ALL STERILIZATION ACTIVITIES WERE CONDUCTED WITH NO NONCONFORMITIES PER STERILIZATION RECORD (OP# 150). ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1223102) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT COULD NOT BE VERIFIED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PAIN. TOOTH LOCATION 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254571 IMP,TSV,3.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1223102

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention