BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM

    MDR report key: 8866628 · Received August 6, 2019

    Report

    Report Number
    0002023141-2019-00516
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    March 12, 2019
    Report Date
    November 23, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). ONE IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM (TSVH10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE, DRIED BLOOD AND BONE AROUND THE IMPLANT AS WELL AS INSIDE THE IMPLANT AROUND THE HEX, AND NO APPARENT MALFUNCTION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENTS COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENTS APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (0203791). 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 EVENTS WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD (#: 15A144) 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: (0203791) FOR SIMILAR EVENTS AND NO OTHER RELEVANT COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENTS (INFECTION & BONE LOSS) WERE NON-VERIFIABLE. 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.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE #29 WAS REMOVED ON (B)(6) 2019 DUE TO PERI-IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659150 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 0203791

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention