BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 10805871 · Received November 6, 2020

    Report

    Report Number
    0002023141-2020-01916
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    February 21, 2019
    Report Date
    November 25, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT (TSVTB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR AND BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENT (NUMBNESS). HOWEVER, MEASUREMENTS WERE TAKEN USING A CALIPER. THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN SPECIFICATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #29 (UNIVERSAL) FOR APPROXIMATELY 3 DAYS. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW FOR THE LOT (1220979) 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 (1220979) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. SEPTEMBER 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 AND DIMENSIONAL ANALYSIS, 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. BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS IMPROPER PATIENT SELECTION OR IMPROPER TECHNIQUES USED DURING PLACEMENT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PATIENT WAS COMPLAINING OF NUMBNESS AT THE IMPLANT SITE AFTER PROCEDURE. IMPLANT MAY OR MAY NOT BE PLACED TOO CLOSE TO THE NERVE. TOOTH LOCATION 29. NO MALFUNCTION OF THE DEVICE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262496 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1220979

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention