BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM

    MDR report key: 15540172 · Received October 4, 2022

    Report

    Report Number
    0002023141-2022-02475
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    July 29, 2022
    Report Date
    March 8, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020092
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). PMA/510(K) NUMBERS: K011028, K01322. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. ONE (1) IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM (TSVWH10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT FRACTURED AT THE COLLAR. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION DID OCCUR. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR DEVICES. 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 CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1238023). 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 (1238023) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE REPORTED EVENTS ARE RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICES AND CANNOT BE RECREATED DUE TO THE NATURE OF THE EVENTS. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION, IFU AND RISK FILE REVIEW, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION ARE DUE TO THE IMPLANT LOADED OUTSIDE OF INDICATIONS LEADING TO A BROKEN, FRACTURED, OR OTHERWISE DAMAGED IMPLANT THAT LEADS TO A DECREASE IN PATIENT FUNCTION. INCORRECT ASSEMBLY OF THE ABUTMENT TO THE IMPLANT (FOR EXAMPLE, ABUTMENT NOT SEATED PROPERLY; SCREW NOT TIGHTENED TO RECOMMENDED TORQUE), USER ERROR, INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CROWN BECAME LOOSE ON IMPLANT SITE #30, LATER THE DOCTOR FOUND THE IMPLANT WAS FRACTURED AND IT WAS REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388152 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWH10 1238023 00889024020092

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention DENTAL SCREW. SEE H10 NARRATIVE.