BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY OCT SYSTEM FRENCH ROD BENDER FOR 3.5MM AND 4.0MM RODS

    MDR report key: 11711477 · Received April 22, 2021

    Report

    Report Number
    1526439-2021-00766
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 26, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXW
    UDI-DI
    10705034530581
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SYMPHONY FRENCH BENDER INNER KNOB BROKE OFF THE FRENCH BENDER. TH FRENCH BENDER LOST THE ABILITY TO HOLD ROD. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM FRENCH ROD BENDER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607348 SYMPHONY OCT SYSTEM FRENCH ROD BENDER FOR 3.5MM AND 4.0MM RODS BENDER HXW DEPUY SPINE INC 2020-00-145 10705034530581

    Patients

    Seq Age Sex Outcome Treatment
    1