BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 13769920 · Received March 15, 2022

    Report

    Report Number
    0002023141-2022-00637
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 23, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED, AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED, PATIENT SEX UNKNOWN / NOT PROVIDED, WEIGHT UNKNOWN / NOT PROVIDED, FAX NUMBER UNKNOWN / NOT PROVIDED,AND ADDITIONAL PMA/510(K) NUMBER ¿ K011028/K013227. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3252. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4307. ONE (1) IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT FRACTURED AT THE COLLAR REGION. SIGNS OF USE. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION HAS OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. 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 LIKELY WITHIN SPECIFICATIONS AND LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1251414). 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 (1251414) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (FRACTURE) AND 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 CAUSES DETERMINED FROM THE INVESTIGATION ARE IMPLANT NOT PLACED PROPERLY; CLINICIAN ERROR. NO FURTHER INVESTIGATION AND NO 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 IMPLANT AT TOOTH SITE #19 FRACTURED DURING INSTALLATION AND WAS REMOVED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47471 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1251414 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention