BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP® INTERSPINOUS SPACER

    MDR report key: 3150047 · Received June 6, 2013

    Report

    Report Number
    2953769-2013-00085
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THAT A PATIENT UNDERWENT A PROCEDURE USING AN INTERSPINOUS SPACER AT L5/S FOR LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT THE "PATIENT DEVELOPED SYMPTOMATIC RECURRENCE ABOUT 3 MONTHS POST-OP" AND A SPINOUS PROCESS FRACTURE WAS OBSERVED ON IMAGES. ACCORDING TO THE REPORT, A REVISION SURGERY "WITH IMPLANT REMOVAL AND PLIF" WAS PERFORMED APPROXIMATELY 7 MONTHS POST-OP. PER THE REPORT, THE SPINOUS PROCESS COLLAPSE OCCURRED AT L5 BUT AN IMPLANT MALFUNCTION WAS NOT NOTED. THE PATIENT WAS REPORTEDLY DOING "QUITE WELL UP TO 1 MONTH POST-OP." NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250565 X-STOP® INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MDT KYPHON SUNNYVALE MFG NA 2245341

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention