BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,13,MTX,MG

    MDR report key: 9035210 · Received September 13, 2019

    Report

    Report Number
    0002023141-2019-00742
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 8, 2019
    Report Date
    November 26, 2019
    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

    A TAPERED SCREW VENT IMPLANT (TSVT4B13) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED IMPLANT IDENTIFIED SIGNS OF USE BUT NO DAMAGE WITHIN THE EXTERNAL THREADS OF THE IMPLANT. THE COLLAR AND INTERNAL HEX OF THE IMPLANT SHOWED SIGNS OF USE BUT NO DAMAGE. VISUAL AND DIMENSIONAL COMPARISON OF THE IMPLANT WITH THE DRAWING (PD-TSVT4B13 REV. B) USING A CALIPER (CAL1334; CALIBRATION DUE: 25-SEP-2020) VERIFIED THAT THE IMPLANT WAS CONSISTENT WITH THE DESIGN. THE IMPLANT WAS LOCATED AT DENTAL POSITION #5 (UNIVERSAL) AND WAS IMPLANTED FOR 7 DAYS. THE PATIENT WAS ALSO REPORTED TO HAVE MODERATE DENSITY BONE AND OSTEOPOROSIS. NO OTHER PRE-EXISTING PATIENT CONDITIONS WERE NOTED ON THE PER OR IN THE COMPLAINT FORM. NO PICTURES OR X-RAYS WERE PROVIDED FOR THE REPORTED EVENTS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1220721). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD (OP#150) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1220721) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (INFECTION, BONE LOSS) OR FOR THE REPORTED DEVICE (TSVT4B13). THEREFORE, BASED ON THE INVESTIGATION, DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENTS (INFECTION, BONE LOSS) ARE NON-VERIFIABLE AS THEY ARE MEDICAL CONDITION EVENTS. HOWEVER, INFECTION AND BONE LOSS ARE LISTED AS A HARM OR POTENTIAL EFFECT OF IMPLANT FAILURE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THIS REPORT IS INTENDED TO SUBMIT ZIMMER BIOMET COMPLAINT (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (TSVT4B13) WAS REMOVED DUE TO INFECTION AND BONE LOSS AT TOOTH LOCATION 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819923 IMP,TSV,4.1,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1220721

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention