BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,13,MTX,MG

    MDR report key: 9649611 · Received January 30, 2020

    Report

    Report Number
    0002023141-2020-00194
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    January 6, 2020
    Report Date
    April 13, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP, TSV, 4.1, 13, MTX, MG (TSVT4B13) ALONG WITH ONE HEAL COLLAR 3.5X4.5, 5MM (HC345 WERE RETURNED FOR INVESTIGATION ATTACHED TO EACH OTHER. VISUAL EVALUATION IDENTIFIED DRIED BLOOD AND BONE ON THE RETURNED DEVICES. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT WAS PERFORMED AND IT WAS DETERMINED THE DEVICES FAILED FUNCTIONAL TESTING AS THEY WERE NOT ABLE TO BE SEPARATED. A PRE-EXISTING CONDITION NOTED BY THE CUSTOMER WAS ALLOGRAFT SITE. THE PATIENT HAD MODERATE (TYPE II) BONE DENSITY. THE REPORTED DEVICES WERE USED ON TOOTH # 9; THE IMPLANT WAS USED FOR 8 MONTHS WHILE THE HEALING COLLAR WAS USED FOR APPROXIMATELY 3 MONTHS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1220721) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT DISENGAGE) OR DEVICES (TSVT4B13 & HC345). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOR BOTH DEVICES, AS THEY WERE UNABLE TO BE SEPARATED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    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). PATIENT WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALING ABUTMENT WAS UNABLE TO BE REMOVED FROM THE IMPLANT (TSVT4B13). EVENT OCCURRED AFTER TWO WEEKS OF IMPLANT PLACEMENT. DOCTOR WAIT ANOTHER TWO WEEKS TO ALLOW IMPLANT TO HEAL AND HEALING ABUTMENT WAS UNABLE TO BE REMOVED. AS A RESULT, IMPLANT WAS REMOVED. ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111479 IMP,TSV,4.1,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1220721

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention