BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 15623964 · Received October 18, 2022

    Report

    Report Number
    0002023141-2022-02621
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    June 8, 2022
    Report Date
    February 21, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER- (B)(6). WEIGHT UNKNOWN / NOT PROVIDED. 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: 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: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4310. H10: NARRATIVE/DATA WAS UPDATED. ONE IMP, TSV, 4.1MM, SBM, 10 (TSV4B10) WAS RETURNED FOR INVESTIGATION. SIGNS OF USE, THERE WAS BONE DEBRIS ON IMPLANT. MEASUREMENTS MATCH DRAWING. NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD CONTRIBUTE TO THE EVENT. BASED ON THE EVALUATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION HAS NOT OCCURRED. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE EVENTS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICES. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (1243333). 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. STERILIZATION RECORD (OP160) 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 (1243333) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE (ALLERGIC REACTION). THE REPORTED EVENT COULD NOT BE RECREATED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS PATIENT SPECIFIC ISSUE (I.E. ALLERGIES, REACTIONS) OR PARAFUNCTIONAL HABITS OF PATIENT. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE 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 PATIENT FELT PAIN AROUND THE IMPLANT AT TOOTH SITE #35 AND CAME TO THE CLINIC FOR EXAMINATION. ALLERGIC REACTION WAS FOUND, AND THE IMPLANT WAS THEN REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390602 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B10 1243333 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention