BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 3031894 · Received April 3, 2013

    Report

    Report Number
    1030489-2013-00925
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4-L5 TO TREAT LSCS. IT WAS REPORTED THAT A POST-OPERATIVE INFECTION WAS CONFIRMED. A REMOVAL SURGERY WAS PERFORMED TWO MONTHS POST OP AND ALL IMPLANTS BUT THE CAGE WERE REMOVED. BONE FUSION WAS NOT COMPLETED. POST- OPERATIVE IMAGES SHOWED THAT THE CAGE FELL FROM THE INTERVERTEBRAL ANTERIORLY, BUT THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136109 CAPSTONE VERTEBRAL BODY SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Other