BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24512566 · Received March 4, 2026

    Report

    Report Number
    0001038806-2026-01148
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    November 7, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 PMA/510(K) #: 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, H11: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSVB10, (IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM), FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED; A FRACTURE HAS BEEN IDENTIFIED ON THE IMPLANTS COLLAR. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1252237. 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 1252237, FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: FUNCTIONAL: FRACTURE: IMPLANT¿ BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CLINICIAN SELECTS IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE FRACTURE HAS BEEN IDENTIFIED ON 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.

    Description of Event or Problem · 0

    DOCTOR REPORTED IMPLANT FRACTURED AT TOOTH SITE 37. IMPLANT WAS PREVIOUSLY INTEGRATED AND HAD TO BE REMOVED. INFLAMMATION WAS REPORTED AS A CONSEQUENCE OF THE EVENT.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT DURING A FOLLOW UP THAT DUE TO IMPLANT FRACTURE, THE SCREW OFTEN CAME LOOSE AND MAY EVENTUALLY HAVE FRACTURED, AS PER INSPECTION'S RESULTS. DOCTOR ALSO CONFIRMED THAT THE IMPLANT FRACTURED BEFORE THE SCREW DID. TOOTH SITE 37. INFLAMMATION WAS REPORTED. IMPLANT WAS PREVIOUSLY INTEGRATED AND HAD TO BE REMOVED. THIS REPORT REFERS TO FRACTURED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583341 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1252237 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1