BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    11G CURETTE

    MDR report key: 23399929 · Received October 28, 2025

    Report

    Report Number
    3015967359-2025-99525
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Report Date
    April 24, 2026
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    OCJ
    UDI-DI
    07613252639794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 2 DEVICES: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 1 DEVICE: SCRAPPED BY CUSTOMER. 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION: 2 DEVICES WERE LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736 11G CURETTE SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY OCJ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 07613252639794

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown