BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSL

    MDR report key: 2840534 · Received October 9, 2012

    Report

    Report Number
    2840534
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    TRANSL
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN L2-3 AND L3-4 LATERAL FUSION WITH INTERBODY DEVICE IMPLANTATION WAS PERFORMED ON (B)(6) 2012. MULTIPLE FLUOROSCOPIC IMAGES WERE TAKEN AND REVIEWED THROUGHOUT THE PROCEDURE. FLUOROSCOPY WAS PERFORMED AFTER SUTURING OF THE INCISION AT THE PLANNED CONCLUSION OF THE CASE WHILE THE PATIENT REMAINED ANESTHETIZED IN THE OPERATING ROOM. AT THIS TIME THE PRESENCE OF TWO OBJECTS (4-5 MM IN SIZE) WERE NOTED IN THE IMAGE. A DECISION WAS MADE TO REOPEN THE SUTURE LINE AND EXPLORE THE AREA. THE OBJECTS WERE LOCATED AND RETRIEVED. THEY WERE IDENTIFIED AS PINS FROM THE TRANS 1 144 MM RETRACTOR TUBE. THE INCISION WAS IRRIGATED AND CLOSED. FINAL FLUOROSCOPY SHOWED NO EVIDENCE OF FOREIGN BODY ASIDE FROM THE PLANNED BIOMECHANICAL DEVICE. THE PATIENT WAS SUBSEQUENTLY INFORMED OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSL 144 MM RETRACTOR TUBE KWQ TRANSL 19328

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention