BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1877492 · Received October 12, 2010

    Report

    Report Number
    2953769-2010-00543
    Event Type
    Injury
    Date Received
    October 12, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE WAS NOT RETURNED; FOLLOWED UP WITH PT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED "BACK PROBLEMS" IN (B)(6) 2007. THE PATIENT UNDERWENT AN X-STOP PROCEDURE (12MM DEVICE) AT LEVEL L4/L5 WITH NO COMPLICATIONS ON (B)(6) 2010. SIX WEEKS POST OPERATIVELY, MUSCLE SWELLING WAS NOTED AT THE UPPER END OF THE INCISION. ON (B)(6) 2010, PATIENT REPORTED DOING WELL, REQUESTING TO PLAY GOLF AGAIN; GIVEN INSTRUCTIONS NOT TO OVER SWING. ON (B)(6) 2010, PATIENT CONTACTED THE PHYSICIAN'S OFFICE FOR RETURN OF PAIN IN THE RIGHT LEG COMING FROM THE BACK RADIATING MEDIALLY INTO THE RIGHT LEG ALL THE WAY TO THE FOOT. REPORTS OF (B)(4) SHOWED SPINOUS FRACTURE AT LEVEL L5 AND EXTENDED INTO AND DISTRACTED THE SUPERIOR ASPECT OF A VERTICAL FRACTURE OF L5 SPINOUS PROCESS. DURING THE LAST VISIT WITH THE PHYSICIAN ON (B)(6) 2010, PATIENT WAS RECOMMENDED TO HAVE A DIAGNOSTIC AND THERAPEUTIC L5 NERVE ROOT INJECTIONS ON THE RIGHT SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN X-STOP PROCEDURE AT LEVEL L4/L5. POST PROCEDURE THE PT FELT SOMETHING WHILE HE WAS GOLFING. THE PT "WOKE UP IN TERRIBLE PAIN AND A FRACTURE". THE DEVICE WAS REPORTEDLY DISLODGED. NO ADDITIONAL INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM INTERSPINOUS PROCESS SPACER NQO MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other