BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 1569123 · Received January 4, 2010

    Report

    Report Number
    2135156-2009-00005
    Event Type
    Injury
    Date Received
    January 4, 2010
    Date of Event
    October 1, 2009
    Report Date
    January 4, 2010
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    EZX
    PMA / PMN Number
    K014200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING CONTAINED IN THIS REPORT IS BEING PROVIDED TO FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY. DEVICE WAS DESTROYED DURING EXPLANT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING CONTAINED IN THIS REPORT IS BEING PROVIDED TO FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY.THIS REPORT WAS SENT TO FDA WITHIN THE 30-DAY REPORTING TIMELINE WHILE WAITING FOR THE APPROVAL. SPINEOLOGY HAS BEEN INFORMED THAT SOFTWARE IS NOT THE OFFICIAL PAPER VERSION OF THE MDR FORM AND MUST EITHER SUBMIT THE PROPER PAPER FORM OR SUBMIT THE MDR. THEREFORE, WE ARE RE-SUBMITTING THIS REPORT. DEVICE WAS DESTROYED DURING EXPLANT

    Description of Event or Problem · 1

    AN OPTIMESH DEVICE WAS IMPLANTED IN A PATIENT TO TREAT A STABLE VERTEBRAL FRACTURE FROM A MOTOR VEHICLE ACCIDENT. AFTER THE PATIENT WAS DISCHARGED, SHE BEGAN TO SUFFER FROM CAUDA EQUINA SYNDROME. THE PATIENT RETURNED TO THE HOSPITAL FOR A CT SCAN, AND IT WAS NOTED THAT THE DEVICE HAD RETROPULSED THROUGH THE POSTERIOR CORTEX INTO THE CENTRAL SPINAL CANAL. THE PATIENT UNDERWENT A CORPECTOMY TO ALLEVIATE THE SYMPTOMS. THE SURGEON PRESENTED THE CASE TO SPINEOLOGY IN 2009, AND IT WAS REVEALED THAT THERE WERE SEVERAL ERRORS MADE UPON IMPLANTATION. THESE ERRORS INCLUDED IMPROPER PREPARATION OF THE FRACTURED VERTEBRAL BODY AND IMPROPER PLACEMENT OF THE DEVICE (PARTIALLY IN THE VERTEBRAL BODY AND PARTIALLY IN THE CENTRAL SPINAL CANAL).

    Description of Event or Problem · 1

    AN OPTIMESH DEVICE WAS IMPLANTED IN A PATIENT TO TREAT A STABLE VERTEBRAL FRACTURE FROM A MOTOR VEHICLE ACCIDENT. AFTER THE PATIENT WAS DISCHARGED, SHE BEGAN TO SUFFER FROM CAUDA EQUINA SYNDROME. THE PATIENT RETURNED TO THE HOSPITAL FOR A CT SCAN, AND IT WAS NOTED THAT THE DEVICE HAD RETROPULSED THROUGH THE POSTERIOR CORTEX INTO THE CENTRAL SPINAL CANAL. THE PATIENT UNDERWENT A CORPECTOMY TO ALLEVIATE THE SYMPTOMS. THERE IS NO EVIDENCE OF DEVICE FAILURE OR IMPROPER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMESH SURGICAL MESH EZX SPINEOLOGY, INC. OPTIMESH 1500 S09031

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention| S