BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA SPINAL SYSTEM

    MDR report key: 769848 · Received August 21, 2006

    Report

    Report Number
    9617297-2006-00002
    Event Type
    Malfunction
    Date Received
    August 21, 2006
    Report Date
    July 26, 2006
    Manufacturer
    U&I CORP.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOT AVAILABLE BECAUSE THE BROKEN SCREW IS STILL IN THE PT IN EARLY AUGUST. WE KEEP CONTACTING OUR DISTRIBUTOR TO GET ADDITIONAL INFO AND TO KNOW WHETHER THE BROKEN SCREW IS REMOVED FROM THE PT OR NOT AND TO KNOW OUTCOMES ATTRIBUTED TO ADVERSE EVENT. SO FAR, NO ADDITIONAL INFO IS AVAILABLE.

    Description of Event or Problem · 1

    PATIENT WITH L4-S1 OPTIMA IMPLANTS, CONSULTED SURGEON AFTER HEARING A "POP" THEN FEELING PAIN. X-RAY SHOWS A BROKEN SCREW (MID-SHAFT) AT S1. THE BROKEN SCREW IS STILL IN THE PT IN EARLY AUGUST. WE ARE STILL ATTEMPTING TO GET ADDITIONAL INFO AND TO KNOW WHETHER THE BROKEN SCREW IS REMOVED FROM THE PT OR NOT AND TO KNOW OUTCOMES ATTRIBUTED TO ADVERSE EVENT. NO INFO IS AVAILABLE AS THE PT MAY KEEP IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA SPINAL SYSTEM OPTIMA PEDICLE SCREW (KWQ, MNH,MNI) KWQ U&I CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other