BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 15396332 · Received September 9, 2022

    Report

    Report Number
    0002023141-2022-02370
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    July 12, 2022
    Report Date
    October 18, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-02345 . WEIGHT UNKNOWN / NOT PROVIDED. 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

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-02345-1. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: TYPE OF INVESTIGATION CODES WERE UPDATED: 3331, 4109, 4110, 4111. H6: INVESTIGATION FINDINGS CODE WAS UPDATED: 213. H6: INVESTIGATION CONCLUSION CODE WAS UPDATED: 67. TWO TAPERED SCREW-VENT IMPLANTS (TSVB10 & TSV4B10) AND COVER SCREW WERE RETURNED FOR INVESTIGATION. THERE WERE NO ALLEGATIONS AGAINST THE COVER SCREW. THEREFORE, THIS INVESTIGATION ADDRESSED ONLY THE IMPLANTS AND THE REPORTED EVENTS. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED BONE/BLOOD RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE AND NO APPARENT SIGNS OF MALFUNCTION. 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 EVENTS. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS 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 PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMVIE. DHR REVIEW FOR THE LOTS (1252150 & 1251483) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1252150 & 1251483) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: BONE FRACTURE AND INABILITY TO PLACE) AND NO OTHER COMPLAINT WAS IDENTIFIED. THE DEVICES COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENTS/FAILURES (BONE FRACTURE AND INABILITY TO PLACE). THEREFORE, THE REPORTED EVENTS COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE PROBABLE CAUSES FOR THE REPORTED EVENT ARE CLINICIAN ERROR (IMPROPER CASE PLANNING AND IMPROPER SURGICAL PROCEDURE). 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 DOCTOR TRIED TO PLACE 2 DIFFERENT SIZE IMPLANTS ON TOOTH #9, BUT THE BONE BROKE OUT ON THE PALATE. THE SITE WAS BONE GRAFTED AND AN IMPLANT WILL BE PLACED IN 3 MONTHS.

    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
    1579284 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B10 1251483 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention