BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3121796 · Received May 21, 2013

    Report

    Report Number
    1030489-2013-01787
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    February 14, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2004, THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY OF HER SPINE FROM C5-7. REPORTEDLY, SHE WAS IMPLANTED WITH RHBMP-2/ACS IN THIS SURGERY. ALLEGEDLY, THE PATIENT'S "POST-OPERATIVE PERIOD WAS MARKED BY A PERIOD OF IMPROVEMENT, FOLLOWED BY PROGRESSIVELY WORSENING NECK PAIN, RADICULOPATHY AND HEADACHES." ON (B)(6) 2007, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SEVERE PAIN AND SYMPTOMS. REPORTEDLY, THE PATIENT "CONTINUES TO EXPERIENCE CHRONIC NECK PAIN, SPASMS, AND SEVERE HEADACHES. SHE ATTENDS REGULAR VISITS WITH HER PAIN MANAGEMENT PHYSICIAN, WHO PERFORMS INJECTIONS IN HER NECK AND BOTOX INJECTIONS FOR HER HEADACHES, AND MONITORS HER MEDICATIONS FOR PAIN AND SPASMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223526 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R