BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 2724409 · Received September 4, 2012

    Report

    Report Number
    2953769-2012-00124
    Event Type
    Injury
    Date Received
    September 4, 2012
    Report Date
    August 6, 2012
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: DAVID H. KIM ET AL. "ASSOCIATION BETWEEN DEGENERATIVE SPONDYLOLISTHESIS AND SPINOUS PROCESS FRACTURE AFTER INTERSPINOUS PROCESS SPACER SURGERY". THE SPINE JOURNAL 12 (2012); 466-472. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. MEAN AGE OF THE STUDY GROUP WAS (B)(6). SEX: 56.4% OF THE STUDY GROUP POPULATION WAS FEMALE. SEVEN PATIENTS ELECTED TO UNDERGO A REVISION SURGERY. DATE OF EVENT IS UNKNOWN. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PROSPECTIVE (B)(6) STUDY THAT 38 PATIENTS UNDERWENT IPS SURGERY FOR LSS (LUMBAR SPINAL STENOSIS) WITH NEUROGENIC CLAUDICATION. IT WAS REPORTED THAT SPINOUS PROCESS FRACTURES WERE IDENTIFIED BY CT (COMPUTED TOMOGRAPHY) IN 9 PATIENTS, ALL OF WHOM PRESENTED WITH DEGENERATIVE SPONDYLOLISTHESIS BEFORE SURGERY. NO FRACTURES WERE APPARENT ON PLAIN RADIOGRAPHS, BUT WERE APPARENT ONLY ON SAGITTAL RECONSTRUCTED IMAGES. THE TIME TO POSTOPERATIVE CT SCAN VARIED FROM 2 WEEKS TO 6 MONTHS. THE RATE OF SPONDYLOLISTHESIS OBSERVED ON PREOPERATIVE RADIOGRAPHS WAS 100% AMONG PATIENTS WITH FRACTURES. IT WAS REPORTED THAT SPINOUS PROCESS FRACTURES WERE OBSERVED AT L4 IN EIGHT PATIENTS, L5 IN TWO PATIENTS, AND L3 IN ONE PATIENT. THE CEPHALAD PROCESS WAS AFFECTED IN 7 CASES AND THE CAUDAD PROCESS IN 3 CASES. THE INTERMEDIATE SPINOUS PROCESS WAS INVOLVED IN ONE CASE ON WHICH TWO IMPLANTS WERE PLACED AT ADJACENT LEVELS. THE PRESENCE OF A SPINOUS PROCESS FRACTURE WAS CONFIRMED INTRAOPERATIVELY IN 7 AFFECTED PATIENTS WHO ELECTED TO UNDERGO REVISION SURGERY. THREE PATIENTS ELECTED TO RETAIN THEIR IMPLANT (NO REVISION SURGERY) AND UNDERWENT A REPEAT CT SCAN AT 12 MONTHS. ALL THREE DEMONSTRATED APPARENT SPONTANEOUS HEALING OF THE SPINOUS PROCESS FRACTURE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MDT KYPHON SUNNYVALE MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention