BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 3012568 · Received March 15, 2013

    Report

    Report Number
    3004485144-2013-00007
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    LANX, INC.
    Product Code
    NKB
    PMA / PMN Number
    120399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED IFU STATES, "CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED. ANY CASE REQUIRING THE MIXING OF COMPONENTS FROM TWO DIFFERENT SYSTEMS." REVIEW OF LABELING FOUND INSTRUCTIONS PERTAINING TO MIXING COMPONENTS FROM DIFFERENT DISTRIBUTORS TO BE SUFFICIENT.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED APPROXIMATELY TWO MONTHS AFTER THE INITIAL SURGERY TO ADDRESS COMPONENT LOOSENING (NON-LANX COMPONENTS) AND MIGRATION WITHIN A POSTERIOR PEDICLE SCREW CONSTRUCT CONTAINING LANX OFFSET CONNECTORS. ALL SCREW AND CONNECTOR COMPONENTS WERE REPLACED. PER THE INITIAL REPORTER, THE FOLLOWING FACTORS CONTRIBUTED TO THE LOOSENING: MIXED USE OF CONSTRUCT COMPONENTS DISTRIBUTED BY LANX AND A COMPETITOR; AND SURGEON'S BELIEF OF PATIENT NON-COMPLIANCE WITH POST-OPERATIVE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110868 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB LANX, INC. 7702-3025

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention COMPETITIVE POSTERIOR PEDICLE SCREW SYS COMPONENTS| ROD (7707-6500)| SET SCREW (7703-1600)