BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 2303095 · Received October 21, 2011

    Report

    Report Number
    1030489-2011-01353
    Event Type
    Injury
    Date Received
    October 21, 2011
    Report Date
    September 21, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7510400, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7510400, PMA# P000058 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS PRODUCT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION USING RHBMP-2/ACS. THE PATIENT COMPLAINED OF PAIN TEN DAYS AFTER THE OPERATION. THE REPORTER CONSIDERED THE PAIN TO BE NEUROGENIC. HOWEVER, MRI SCANS HAVE NOT REVEALED A PHYSICAL REASON FOR THE PAIN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention