BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM

    MDR report key: 22325099 · Received June 24, 2025

    Report

    Report Number
    0002023141-2025-01708
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 8, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019560
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K011028, K013227.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVH10 (IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. FRACTURE IDENTIFIED AT THE COLLAR. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1253960. 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 1253960 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: FUNCTIONAL: FRACTURE: IMPLANT.¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER (B)(4) REV 5, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION HAS OCCURRED. THE IMPLANT WAS FRACTURED AT THE COLLAR. THE REPORTED EVENT IS CONFIRMED. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS IT WAS FRACTURED. PATIENT PRESENTED FOR IMPLANT REMOVAL OF IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390204 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1253960 00889024019560

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention