BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15451093 · Received September 19, 2022

    Report

    Report Number
    0002023141-2022-02423
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    July 13, 2022
    Report Date
    February 28, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE UPDATED: 3331, 4109, 4110, 4111, 4114. H6: INVESTIGATION FINDINGS CODE WAS UPDATED: 213. H6: INVESTIGATION CONCLUSION CODE WAS UPDATED: 4315. H10: NARRATIVE/DATA WAS UPDATED. ONE (1) IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) WAS NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM AND LOT NUMBER ALONG WITH THE APPLICABLE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND RISK FILE. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1244047). 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 (1244047) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS CLINICIAN ERROR -- IMPROPER SURGICAL PROCEDURE. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION: A REPLACEMENT IMPLANT WAS UNABLE TO BE PLACED. THE FOLLOWING SECTIONS ARE BEING REPORTED: B1: REPORT TYPE WAS UPDATED. B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT WAS UPDATED. B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H1: TYPE OF REPORTABLE EVENT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H10: NARRATIVE/DATA WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MOUNT WOULD NOT DISENGAGE FROM THE IMPLANT AT THE TIME OF PLACEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THIS TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON FOLLOW UP, THE IMPLANT COORDINATOR STATED THAT THEY DID NOT COMPLETE THE PROCEDURE WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837378 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1244047 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention