BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF SYSTEM

    MDR report key: 675968 · Received February 14, 2006

    Report

    Report Number
    3004578806-2006-00002
    Event Type
    Injury
    Date Received
    February 14, 2006
    Date of Event
    January 18, 2006
    Report Date
    February 10, 2006
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT HE NOTICED UNUSUAL RESISTANCE WHEN CREATING THE PRESACRAL ACCESS CHANNEL DURING SURGERY. PT WAS NOT DISCHARGED 2 DAYS LATER, AS SCHEDULED, DUE TO THE PT NOT FEELING WELL. IT WAS DECIDED TO HOLD THE PT OVER THE WEEKEND. DRAINAGE FROM THE INCISION WAS OBSERVED. A COLORECTAL SURGEON WAS CONSULTED. COLORECTAL SURGEON ORDERED AN ENEMA. THE ENEMA REVEALED LEAKAGE INTO THE PRE-SACRAL SPACE. A RIGID SCOPE WAS USED TO EXAMINE THE RECTUM. IT WAS FAIRLY CLEAN. THROUGH DIGITAL EXAM AND THROUGH REOPENING THE INCISION, IT WAS DISCOVERED THAT THERE WAS PRE-EXISTING SCAR TISSUE PRESENT THAT WAS RIGIDLY FIXING THE RECTUM TO THE COCCYX. THIS SCAR TISSUE WAS UNDETECTED PRIOR TO THE PROCEDURE. A LACERATION IN THE RECTUM WAS DISCOVERED APROXIMATELY 1-2CM FROM THE TIP OF THE COCCYX. THERE IS NO EVIDENCE OF PERITONITIS. THE POSSIBILITY OF AN INFECTION IN THE DISC SPACE IS THOUGHT BY THE SURGEON TO BE MINIMAL BASED UPON HIS PRE-OPERATIVE PREPARATION ROUTINE WHICH INCLUDES ANTIBIOTICS COMBINED WITH THE FACT THAT THE IMPLANT PASSES ONLY THROUGH A PROTECTED CHANNEL. A TEMPORARY LAPAROSCOPIC COLOSTOMY WAS DONE. THE CARE OF THIE PT HAS BEEN TURNED OVER TO THE COLORECTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION IMPLANT JDN TRANS1 INCORPORATED NA 043113605D

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention