BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1991021 · Received February 11, 2011

    Report

    Report Number
    3004485144-2011-00021
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 13, 2011
    Manufacturer
    LANX, LLC
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED BECAUSE THERE WAS NO DEVICE MALFUNCTION OR PROBLEM. PER THE DEVICE LABELING (B)(4). NON-UNION IS LISTED AS A POSSIBLE COMPLICATION ASSOCIATED WITH A SPINAL SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    DURING A PLANNED REMOVAL OF A LUMBAR SPINAL FUSION CONSTRUCT FOLLOWING FUSION, THE SURGEON DISCOVERED THAT THE PT HAD NOT FUSED AT ONE OF TWO LEVELS. THE ORIGINAL CONSTRUCT WAS IMPLANTED ON (B)(6) 2010. THE SURGEON RE-INSTRUMENTED AT THE SINGLE LEVEL THAT PRESENTED WITHOUT FUSION WITH ADDITIONAL ALLOGRAFT. THERE WAS NO DEVICE PROBLEM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM NKB LANX, LLC 7715-75XX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention PEEK INTERBODY| ALLOGRAFT