BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    MDR report key: 21562307 · Received March 10, 2025

    Report

    Report Number
    0002023141-2025-00604
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 17, 2025
    Report Date
    June 23, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019577
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVH11, (IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE RETURNED IMPLANT HAS SIGNS OF USE. THE IMPLANT WAS TREPHINED. THE IMPLANT HAD BONE DEBRIS ON THE EXTERNAL THREADS. THE IMPLANTS COLLAR WAS FRACTURED AND HAD AN IRT TOOL STUCK INSIDE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1223629. 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 1223629 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 RM-00541-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE IMPLANT WAS FRACTURED AT THE COLLAR. THE REPORTED EVENT WAS 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 FRACTURE IMPLANT + STUCK IMPLANT REMOVAL TOOL. THE PATIENT WAS A HEAVY WEIGHT-BEARER, AND AFTER 5 YEARS, THE UPPER PART OF THE IMPLANT BODY ALSO FRACTURED, SO IT WAS REMOVED. A REPLACEMENT FIXTURE WILL BE INSERTED SOON. THE IRT ALSO BECAME STUCK DURING REMOVAL, SO IT WAS RETURNED IN ITS ATTACHED STATE. TOOTH SITE #4.

    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
    2104802 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1223629 00889024019577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention