BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1600406 · Received January 25, 2010

    Report

    Report Number
    1600406
    Event Type
    Injury
    Date Received
    January 25, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 25, 2010
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADULT PATIENT WENT TO OR FOR POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5. DURING THE SURGERY, WHILE ROTATING THE BLADE OF A 7MM INTERVERTEBRAL DISC EXCISOR, THE HEAD OF THE INSTRUMENT BROKE OFF, LEAVING THE PIECE IN THE L4-5 DISC SPACE. RETRIEVAL OF THE PIECE WOULD HAVE REQUIRED AN ANTERIOR SURGICAL APPROACH, SO THE PIECE REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTERVERTEBRAL DISC EXCISOR LXH SYNTHES (USA) PRODUCTS LLC * A7 MA 07

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention OTHER