BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 9363669 · Received November 22, 2019

    Report

    Report Number
    0002023141-2019-01164
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    April 23, 2019
    Report Date
    January 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AN IMP,TSV,4.7,8,MTX,MG (ITEM # TSVTWB8) WAS RECEIVED FOR INVESTIGATION WITH ITS COVER SCREW. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURES AROUND THE IMPLANT COLLAR AND DAMAGE TO THE DRIVE FEATURE. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1220986). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (LOT # 1220986) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAD OCCURRED 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: EXPIRATION DATE AND UDI. G4: DATE RECEIVED BY MANUFACTURER. G7: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE 'NO' TO 'YES'. H4: DEVICE MANUFACTURE DATE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DATE OF BIRTH UNKNOWN / NOT PROVIDED, PATIENT SEX UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBERS: K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO FRACTURE. TOOTH LOCATION 35.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156097 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1220986

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention