BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22708040 · Received August 4, 2025

    Report

    Report Number
    0002023141-2025-02160
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    March 27, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. E1: REPORTER NAME AND ADDRESS UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K061410/K011028/K013227.

    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) TSVB10, (IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICES IDENTIFIED THE IMPLANT AND MOUNT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO THE IMPLANT'S EXTERNAL THREADS. DURING A FUNCTIONAL / PHYSICAL TEST, THE IMPLANT AND MOUNT DISENGAGED AS INTENDED. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1270736. 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 1270736 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DOES NOT DISENGAGE/RELEASE¿ A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENT HAS BEEN UNCONFIRMED FOLLOWING FUNCTIONAL TESTING AND PHYSICAL EVALUATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, A DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS UNCONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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 DURING THE PROCEDURE THE MOUNT WOULD NOT DETACH FROM THE IMPLANT. PROCEDURE COMPLETED. BONE TYPE II.

    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
    2277411 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1270736 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown