BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 4289957 · Received November 26, 2014

    Report

    Report Number
    3004485144-2014-00023
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    BIOMET SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K120399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGERY TO ADDRESS DISEASE PROGRESSION AT THE ADJACENT LEVEL, THE SURGEON CHOSE TO REMOVE THE PEDICLE SCREW CONSTRUCT IMPLANTED DURING A PREVIOUS SURGERY ONE LEVEL DOWN. THE ORIGINAL CONSTRUCT PERFORMED AS INTENDED AS INDICATED BY FUSION PRESENT AT THE LEVEL AND WAS ALSO REMOVED WITHOUT INCIDENT. THERE ARE NO INDICATIONS THAT THE PEDICLE SCREW CONSTRUCT MALFUNCTIONED. THIS MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW CONDUCTED BY BIOMET SPINE. THIS RETROSPECTIVE REVIEW WAS COMPLETED IN RESPONSE TO AN FDA FORM 483 ISSUED TO BIOMET SPINE DURING AN FDA ON-SITE INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769705 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB BIOMET SPINE, LLC 7715-6540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SET SCREW, MODEL:7703-1600,| PEDICLE SCREW, MODEL:7715-6545,| ROD, MODEL:7701-1045| ROD, MODEL:7701-1010,