BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX FUSION SYSTEM

    MDR report key: 2492391 · Received March 13, 2012

    Report

    Report Number
    3004485144-2012-00014
    Event Type
    Other
    Date Received
    March 13, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MQP
    PMA / PMN Number
    102738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO IMPLANTS WERE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED. A REVIEW OF THE DHR FOR THE REPORTED PRODUCT INDICATED NO DISCREPANCIES WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE DEVICE DISLODGED DURING ATTEMPTED INSERTION AS A RESULT OF A BENT INSERTER. A REVIEW OF THE RETURNED INSTRUMENT COULD NOT CONFIRM THE ALLEGED DEFORMATION WHICH WAS REPORTED TO HAVE CAUSED THE DISLODGE OF THE IMPLANT COMPONENTS. THE DEVICE WAS RETURNED IN A FULLY FUNCTIONAL STATE. AS A RESULT, THE CAUSE OF THE DISLODGE AND ADDITIONAL SURGICAL TIME TO RE-ATTACH THE DEVICE WAS LIKELY THE RESULT OF INHERENT SURGICAL DIFFICULTY OF INSERTING THE DEVICE INTO THE DISC SPACE.

    Description of Event or Problem · 1

    THE SURGEON EXPERIENCED A 30 MINUTE SURGICAL DELAY IN ORDER TO RE-ATTACH THE ANCHORED PLATE TO THE INTERBODY COMPONENT IN SITU, AFTER THE COMPONENTS DISLODGED DURING IMPACTION INTO THE DISC SPACE. THE PLATE WAS RE-ATTACHED WITHOUT FURTHER INCIDENT OR IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MQP LANX, INC. L534803

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention (B)(4) (INSERTER)| INTERBODY COMPONENT MENTIONED ABOVE| (B)(4) (ANCHROED PLATE)