BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2031045 · Received March 22, 2011

    Report

    Report Number
    3004485144-2011-00026
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    LANX, LLC.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO EXPLANTED PEDICLE SCREWS ARE (MODEL 7715-6545/LOT L516305; MODEL 7715-7540/LOT LX-2270). METHOD: THE SPINOUS PROCESS FUSION PLATE WAS NOT RETURNED BECAUSE IT WAS REMOVED INTACT WITH THE SPINOUS PROCESS. AN EVALUATION COULD NOT BE PERFORMED. VISUAL EXAMINATION OF THE RETURNED PEDICLE SCREWS DID NOT IDENTIFY A FAILURE AND NONE WAS REPORTED. BASED ON A REVIEW OF THE OPERATIVE NOTES THE POST-OPERATIVE DIAGNOSIS WAS THE SAME, INDICATING PSEUDOARTHROSIS. THE SURGEON PLACED A SECOND INTERBODY CAGE; THE FIRST CAGE FROM THE INDEX SURGERY WAS LEFT IN PLACE. AUTOGRAFT AND AUTOLOGOUS MORSELLIZED BONE, AND BMP WAS PLACED IN THE DISK SPACE. THE L5-S1 WAS RE-FIXATED WITH BILATERAL PEDICLE SCREWS.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT FOLLOW-UP LUMBAR FUSION SURGERY. PRE-OPERATIVE DIAGNOSIS INDICATED PSEUDOARTHROSIS L5-S1, BILATERAL PROXIMAL LUMBAR RADICULOPATHY, AND LUMBAGO. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2011 TO ADDRESS DISCOGENIC BACK PAIN, LUMBAGO, AND RIGHT LOWER EXTREMITY AND RADICULOPATHY. THE FOLLOW-UP SURGERY REQUIRED REMOVAL OF A SPINOUS PROCESS FUSION PLATE AND REMOVAL OF UNILATERAL PEDICLE SCREWS. A LAMINECTOMY, FORAMINOTOMIES, AND FURTHER DECOMPRESSION OF L5-S1 WAS PERFORMED. OPERATIVE NOTES DO NOT INDICATE A MALFUNCTION OF THE IMPLANTS AND NONE WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINOUS PROCESS FUSION PLATE NKB LANX, LLC. 6201-0008

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention ALLOGRAFT| BMP| AUTOGRAFT| PEEK INTERBODY SPACER