BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2169515 · Received July 15, 2011

    Report

    Report Number
    3004485144-2011-00046
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    LANX, INC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INITIAL REPORTER, THE REVISION SURGERY WAS NOT BECAUSE OF A PRODUCT PROBLEM; THERE WAS NO DEVICE FAILURE. THE EVENT WAS RELATED TO POSITIONING OF THE DEVICE IN PROXIMITY TO A NERVE. A REVIEW OF THE INSTRUCTIONS FOR USE OUTLINES USER ATTENTION TO THE TYPE AND SIZE OF IMPLANT APPROPRIATE TO THE PATIENT AND THE POSITIONING OF THE IMPLANT. METHOD: NO DEVICES WERE MADE AVAILABLE FOR INVESTIGATION. CONCLUSIONS: POSITIONING OF THE DEVICE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2011 ON L3-S1 WITH DIAGNOSIS OF SPONDYLOLISTHESIS AND RADICULAR NERVE PAIN. THE PATIENT PRESENTED POST SURGICALLY WITH CONTINUED SYMPTOMS OF RADICULAR PAIN. THE SURGEON DECIDED TO REVISE THE CONSTRUCT ON (B)(6) 2011 BASED ON CT SCANS TO ADJUST TWO SCREWS LATERALLY BECAUSE OF CLOSE PROXIMITY TO A NERVE. DURING THE REVISION, THE SURGEON REPLACED THE SCREWS AT LEFT L5 AND S1, AND ALSO REPLACED THE LEFT ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWP LANX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALSO EXPLANTED:| SET SCREW: (B)(4)| TWO PEDICLE SCREWS: (B)(4)