BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 23082368 · Received September 18, 2025

    Report

    Report Number
    0002023141-2025-02544
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    December 19, 2024
    Report Date
    October 27, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K011028/K013227. H6: EVENT PROBLEM CODES ¿ PATIENT CODE: 1690 ABSCESS, 1932 INFLAMMATION, 1994 PAIN.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, B5: DESCRIBE EVENT OR PROBLEM, G3: DATE RECEIVED BY MANUFACTURER, G6: TYPE OF REPORT, H1: TYPE OF REPORTABLE EVENT, H2: FOLLOW UP TYPE, H3: DEVICE EVALUATED BY MANUFACTURER, H6: ADVERSE EVENT PROBLEM, H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSVWB8, (IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM) FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED. THE RETURNED IMPLANT HAS SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS AND WAS ATTACHED TO A CROWN. THE IMPLANT WAS IDENTIFIED FRACTURED AT THE COLLAR REGION. IMPLANT MATCHED PRINTS WHERE MEASURED. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1240678. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1240678 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL: FUNCTIONAL: FRACTURE: IMPLANT AND DENTAL: MEDICAL: BONE LOSS + INFECTION¿ BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PATIENT FACTORS. FOR ¿BONE LOSS + INFECTION¿. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS AND INFECTION EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS AND INFECTION HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, MALFUNCTION DID OCCUR. FRACTURE IDENTIFIED AT THE COLLAR. THE REPORTED EVENT WAS CONFIRMED FOLLOWING PHYSICAL EVALUATION. BONE LOSS + INFECTION IS A NON-VERIFIABLE EVENT. 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED, AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 36 FAILED BECAUSE IT FRACTURED AT THE NECK. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR ALSO REPORTED INFLAMMATION, PAIN, EDEMA, ABSCESS, INFECTION AND BONE LOSS

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705885 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1240678 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Required Intervention