BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    OPTABLATE 11G HAND DRILL PACK

    MDR report key: 23368870 · Received October 23, 2025

    Report

    Report Number
    3015967359-2025-99301
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Report Date
    October 23, 2025
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    OCJ
    UDI-DI
    07613327591552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS) 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE PRODUCT DISPOSITION 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED ADDITIONAL INFORMATION 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS 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 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699101 OPTABLATE 11G HAND DRILL PACK SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY OCJ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 07613327591552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown