BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1923438 · Received December 13, 2010

    Report

    Report Number
    2953769-2010-00607
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD - FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED RELIEF OF SYMPTOMS FOR 3-4 WEEKS FROM AN ¿INJECTION¿ GIVEN A FEW MONTHS PRIOR TO THE X-STOP PROCEDURE. THE SYMPTOMS RETURNED AND THE PATIENT HAD BILATERAL LEG PAIN, WORSE WHEN STANDING OR WALKING, AND MINIMAL BACK PAIN. X-STOP PROCEDURE PERFORMED - NOV 08, 2010 AT LEVEL L4-5. X-STOP DEVICE REMOVED ON NOV 29, 2010 AND CORTICAL PEDICLE SCREW FIXATION L3-5, LUMBAR DECOMPRESSIVE LAMINECTOMY L3-5, AND POSTEROLATERAL FUSION USING MASTERGRAFT/INFUSE/AUTOLOGOUS BONE WAS PERFORMED. AT DEC 14, 2010 POST-OP VISIT, PATIENT COMPLAINED OF CONTINUING BACK PAIN, BILATERAL LEG PAIN AND RIGHT BUTTOCK PAIN RADIATING IN A RADICULAR PATTERN. DEC 20, 2010 PATIENT UNDERWENT POSTERIOR LUMBAR FUSION WITH PEDICLE SCREW FIXATION OF L3-S1, BILATERAL FORAMINOTOMY OF L4-L5, POSTEROLATERAL FUSION USING X-STOP/INFUSE AUTOLOGOUS BONE, STEALTH COMPUTERIZED NAVIGATION, INTRAOPERATIVE FLUOROSCOPY WITH INTERPRETATION, STIMULUS EVOKED EMG MONITORING, AND REMOVAL OF ALL HARDWARE OF L3-L5. POST-OP VISIT ON DEC 28, 2010, PATIENT DEVELOPED SEVERE RIGHT SHIN PAIN WHICH CONTINUED TO CAUSE PAIN AND DID NOT IMPROVE WITH MEDICATION INCLUDING LYRICA AND PERCOCET; HOWEVER, DID NOT COMPLAIN OF BACK AND LEFT LEG PAIN. ON DEC 31, 2011, PATIENT UNDERWENT RIGHT L4 NERVE ROOT DECOMPRESSION AND REMOVAL OF A RIGHT L4 PEDICLE SCREW. POST-OP VISIT JAN 11, 2011, PATIENT FEELING FAIRLY WELL WITH SOME DISCOMFORT IN THE LEGS. RIGHT LEG SYMPTOMS RESOLVED SINCE THEN; HOWEVER, CONTINUES TO HAVE PAIN IN THE LEFT KNEE. PATIENT IS TAKING MINIMAL PAIN MEDICATIONS. PATIENT WILL RETURN IN ONE MONTH FOR FOLLOW UP AND X-RAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POSTMARKET CLINICAL STUDY PATIENT UNDERWENT AN X-STOP PROCEDURE AT LEVEL L4/L5. THE PATIENT RETURNED FOR THE FIRST POST-OP VISIT AND REPORTED HAVING INCREASED PAIN ONE DAY POSTOPERATIVE. IT WAS ALSO NOTED THAT "THERE MAY HAVE BEEN SOME SLIPPAGE". THE DEVICE WAS REMOVED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SPINE LLC. 2222521

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other