BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIALIF 2L+

    MDR report key: 3842287 · Received June 1, 2014

    Report

    Report Number
    3004578806-2014-00003
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    February 5, 2013
    Report Date
    May 2, 2014
    Manufacturer
    BAXANO SURGICAL
    Product Code
    KWQ
    PMA / PMN Number
    K102334
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON INDICATED IN HIS MEDICAL OPINION THE CAUSE OF THE INFECTION WAS MOST LIKELY VIA THE ENTRANCE POINT AND INTRODUCED FROM THE SKIN; THE INITIAL SOURCE OF INFECTION REMAINS UNDETERMINED. THE IMPLANT WAS SUCCESSFULLY REMOVED AND THE PATIENT WILL BE TREATED WITH ANTIBIOTICS. THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REGARDING IMPLANT REVISION.

    Description of Event or Problem · 1

    REPORT OF PERICOCCYGEAL SINUS, INDEX PROCEDURE PERFORMED ON 2013-(B)(6). THE SURGEON THOUGHT THE SINUS WAS COMPLETELY EXCISED FROM THE PRESACRAL AREA, BUT THE PATIENT LATER PRESENTED WITH SOME IMPLANT SUBSIDENCE AND INFECTION ON 2014-(B)(6) (DATE MANUFACTURER AWARE). THE IMPLANT WILL BE REMOVED, REVISION SCHEDULED FOR 2014-(B)(6). A FOLLOW-UP REPORT WILL BE ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320638 AXIALIF 2L+ ANTERIOR SPINAL FIXATION KWQ BAXANO SURGICAL 25-3061 043T07711C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention