BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 1952873 · Received January 7, 2011

    Report

    Report Number
    1030489-2011-00019
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROGENIX DBM PUTTY, PROCODE MBP, CATALOG NUMBER 006005, LOT NUMBER 140114005, MANUFACTURE DATE: 6/28/2010, EXPIRATION DATE 6/29/2012. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2991022, 510K # K073291 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR POSTERIOR SURGERY FOR L3-L4 FORAMINAL DISC. APPROXIMATELY 1 MONTH POST-OP, THE PATIENT DEVELOPED SIGNS AND SYMPTOMS OF DISC SPACE INFECTION. THE INFECTION WAS REPORTED TO BE (B)(6). 33 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY TO DEBRIDE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM MAX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGENIX DBM PUTTY