BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    10G CURETTE

    MDR report key: 11218301 · Received January 22, 2021

    Report

    Report Number
    0001811755-2021-00326
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    December 31, 2020
    Report Date
    January 22, 2021
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    OCJ
    UDI-DI
    07613252574187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED. DEVICE NOT ACCESSIBLE FOR TESTING.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115973 10G CURETTE SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY OCJ STRYKER INSTRUMENTS-PUERTO RICO 0306620000 VMSR 07613252574187

    Patients

    Seq Age Sex Outcome Treatment
    1