BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP® INTERSPINOUS SPACER

    MDR report key: 2781352 · Received October 10, 2012

    Report

    Report Number
    2953769-2012-00144
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE USING AN INTERSPINOUS SPACER SYSTEM TO TREAT LUMBAR CANAL STENOSIS AND THE PROCEDURE WAS COMPLETED WITHOUT ANY INCIDENT. IT WAS REPORTED THAT A SPINOUS PROCESS FRACTURED APPROXIMATELY ONE MOTH POST-OP WHEN THE PATIENT LIFTED A 15KG BAG. AS A RESULT, THE SPACER BECAME DISLOCATED AND THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE SPACER AND TO ADD A CONSTRUCT VIA PLIF. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP® INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MDT KYPHON SUNNYVALE MFG NA 2234731

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention