BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1692124 · Received May 15, 2010

    Report

    Report Number
    3004485144-2010-00005
    Event Type
    Injury
    Date Received
    May 15, 2010
    Report Date
    April 16, 2010
    Manufacturer
    LANX, INC
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS NOT KNOWN, BUT ALLEGEDLY OCCURRED SOMETIME BETWEEN (B) (6) 2009 AND (B) (6) 2010. ADDITIONAL INFORMATION PERTAINING TO THE EVENT WAS NOT PROVIDED, INCLUDING PRODUCT INFORMATION, PATIENT INFORMATION, AND THE DATE THE DEVICE WAS IMPLANTED AND EXPLANTED. THE DISTRIBUTOR REPRESENTATIVE INDICATED THAT THERE WAS SOME INFORMATION TO SUGGEST NON-UNION OF THE SPINAL SEGMENTS. THE DEVICE WAS NOT RETAINED FOR EVALUATION. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DRAW A CONCLUSION FOR THE ALLEGED SCREW BREAK, ALTHOUGH LACK OF FUSION APPEARS TO BE THE PROBABLE CAUSE. THE DEVICE IS INTENDED FOR TEMPORARY FIXATION TO IMMOBILIZE AND STABILIZE THE SPINAL SEGMENTS WHILE AWAITING BONY FUSION TO TAKE PLACE. AFTER SOLID FUSION OCCURS, THE SYSTEM SERVES NO FUNCTIONAL PURPOSE. A LACK OF FUSION CAN LEAD TO MATERIAL FATIGUE AND EVENTUAL FAILURE OF THE IMPLANT.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A BROKEN PEDICLE SCREW. THE PATIENT HAD APPARENTLY COMPLAINED OF CONTINUED PAIN POST-OP. INFORMATION RECEIVED SUGGESTS THAT A NON-UNION OF THE VERTEBRAE CONTRIBUTED TO THE SCREW BREAK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention