BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX SYSTEM

    MDR report key: 10262744 · Received July 13, 2020

    Report

    Report Number
    1030489-2020-00877
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 13, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    FSZ
    UDI-DI
    00721902663444
    PMA / PMN Number
    K993021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH STENOSIS SPONDYLOLISTHESIS FOR SPINAL THERAPY. PATIENT DEMOGRAPHICS: GENDER: MALE; AGE: (B)(6). OUTCOME: ALIVE NO INJURY. EVENT WAS INTRA-OP. PROCEDURE USED WAS MAST TLIF. LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT THE LIGHT SOURCE IS INSERTED INTO THE METRX TUBE PER ITS IFU. HOWEVER, AFTER ABOUT AN HOUR, THE LIGHT SOURCE COMES APART AT THE END. THE TWO PIECES OF METAL BASICALLY SPLIT IN TWO, WITH ONE PIECE FALLING OFF, EXPOSING THE LIGHT. OF COURSE THE LIGHT IS HOT SO THIS POSES A BURN RISK TO THE PATIENT AS WELL AS THE SURGICAL STAFF. IT ALSO POSES A FIRE HAZARD TO THE PATIENT AND THE OR. LASTLY, THERE IS THE POTENTIAL FOR THE ONE PIECE OF METAL THAT FALLS OFF TO BECOME LODGED INTO THE PATIENT OR FALL INTO THE WOULD BE UNKNOWN TO THE SURGEON AND STAFF. FORTUNATELY IN THIS CASE, NONE OF THESE MORE SERIOUS ISSUES OCCURRED. THE LIGHTS AND THE PIECE OF DISASSOCIATED METAL WERE REMOVED FROM THE PATIENT AND DISCARDED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730782 METRX SYSTEM LIGHT, SURGICAL, CARRIER FSZ WARSAW ORTHOPEDICS 9560757 0715120W 00721902663444

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR