BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,10,MTX,MG

    MDR report key: 10409064 · Received August 14, 2020

    Report

    Report Number
    0002023141-2020-01250
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    June 26, 2020
    Report Date
    October 21, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT (TSVT4B10) AND HEALING COLLAR WERE RETURNED FOR INVESTIGATION. THE REPORTED EVENT OCCURRED AT TISSUE LEVEL. THEREFORE, THE INVESTIGATION WAS CENTERED ONLY ON THE IMPLANT. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED SIGNS OF WEAR AND BONE RESIDUE DUE TO USAGE. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED FAILURE (PAIN). HOWEVER, MEASUREMENTS WERE TAKEN USING A CALIPER. THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATION. PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY TYPE I. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #30 FOR APPROXIMATELY 11 DAYS. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW FOR THE LOT (1232982) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 (1232982) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT ANATOMICAL CONDITIONS WERE UNKNOWN/NON-VERIFIABLE. THE FOLLOWING SECTION HAS BEEN CORRECTED: H4: MANUFACTURER DATE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSVT4B10) WAS REMOVED DUE TO PAIN AFTER PROCEDURE. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873892 IMP,TSV,4.1,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1232982

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention