BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINOUS PROCESS FUSION PLATE

    MDR report key: 2064549 · Received March 17, 2011

    Report

    Report Number
    3004485144-2011-00027
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 31, 2010
    Report Date
    February 14, 2011
    Manufacturer
    LANX, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES RETURNED. AN EVAL COULD NOT BE PERFORMED. RESULTS: THE DEVICE WAS NOT USED ACCORDING TO LABELED INDICATIONS. LABELING FOR THE DEVICE WAS REVIEWED FOR THE TIME OF SURGERY, AND PER K090252, THE "LANX SPINOUS PROCESS FUSION PLATE (SPFP) IS A POSTERIOR, NON-PEDICLE SUPPLEMENTAL FIXATION DEVICE, INTENDED FOR USE AT A SINGLE-LEVEL IN THE NON-CERVICAL SPINE T1-S1." LANX HAS NOT BEEN MADE AWARE OF THE EVENT FROM ANY OTHER SOURCE. SALES RECORDS DO NOT CONCLUSIVELY IDENTIFY USE OF A LANX DEVICE WITH A "SPINEOLOGY BAG." FURTHER F/U WITH THE DISTRIBUTOR REPRESENTATIVES CONCLUDED THAT THE SURGEONS IDENTIFIED DO NOT USE "SPINEOLOGY BAGS." BASED ON THE LACK OF INFO, A USER FACILITY COULD NOT BE IDENTIFIED FOR F/U. BECAUSE OF THE LACK OF INFO, A CONCLUSION COULD NOT BE DETERMINED. TWO ADDITIONAL SPINOUS PROCESS FUSION PLATES IDENTIFIED IN THE MAUDE REPORT ARE MODEL # (B)(4).

    Description of Event or Problem · 1

    LANX WAS MADE AWARE OF MAUDE ADVERSE EVENT REPORT (B)(4). ACCORDING TO THE REPORT THE PT "HAD A 3 LEVEL LUMBAR FUSION, L3-S1 DUE TO DEGENERATIVE DISK DISEASE, STENOSIS, AND INSTABILITY." THE PT'S DISCOMFORT CONTINUED POST-OPERATIVE AND SOMETIME IN THE SAME YR SHE HAD A F/U SURGERY AND "REMOVED THE ASPEN DEVICES AND BAGS AND DID A TRADITIONAL FUSION." THE REPORT NOTES A TRADITIONAL FUSION WAS PERFORMED, BUT THE TYPE OF DEVICE IS NOT DESCRIBED IN THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINOUS PROCESS FUSION PLATE SPINOUS PROCESS FUSION PLATE KWP LANX, INC. 6211-0014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention "SPINEOLOGY BAGS"