BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP® INTERSPINOUS SPACER

    MDR report key: 3010755 · Received March 19, 2013

    Report

    Report Number
    2953769-2013-00045
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    September 25, 2012
    Report Date
    February 19, 2013
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PAIN RELIEF, INADEQUATE. 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 THAT A STUDY PATIENT WAS IMPLANTED WITH A 10-MM PEEK INTERSPINOUS SPACER DEVICE. APPROXIMATELY 3 MONTHS POSTOPERATIVELY, THE PATIENT REPORTEDLY "DID NOT HAVE ANY RELIEF WITH LOWER EXTREMITY PAIN". THE SITE REPORTED THAT THE PATIENT "FAILED MINIMALLY INVASIVE EFFORT IN THE FORM OF INTERSPINOUS PROCESS SPACER". APPROXIMATELY 5 MONTHS POSTOPERATIVELY, THE PATIENT UNDERWENT AN L3-L4 AND L4-L5 INTERSPINOUS SPACER REMOVAL WITH AN L3-L4 LAMINECTOMY AND LEFT SIDED L3, L4, AND L5 FORAMINOECTOMIES. PER THE OPERATIVE NOTE, THE PRE AND POSTOPERATIVE DIAGNOSES WERE LUMBAR SPINAL STENOSIS, LUMBAR RADICULOPATHY AND STATUS POST INTERSPINOUS PROCESS SPACER PROCEDURE, L3-L4 AND L4-L5. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113169 X-STOP® INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MDT KYPHON SUNNYVALE MFG NA 2237901

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention 10MM PEEK INTERSPINOUS SPACER