BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 13546864 · Received February 16, 2022

    Report

    Report Number
    1030489-2022-00155
    Event Type
    Injury
    Date Received
    February 16, 2022
    Report Date
    February 17, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. B2: OTHER : INFLAMMATION, OSTEOLYSIS. H6: 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. . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. ADVERSE EVENT: OTHER: INFLAMMATION, OSTEOLYSIS. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE INFORMATION WAS RECEIVED FROM HEALTH ACRE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR ALIF SPINAL THERAP Y. IT WAS REPORTED THAT PATIENT UNDERWENT A ALIF IN (B)(6) 2021 AND HAS PERSISTENT PAIN IN HER LUMBAR SPINE WITH MRI FINDINGS SUGGESTING TO BE CONSISTENT WITH POSSIBLE BMP INFLAMMATORY REACTION. PATIENT IS EXPERIENCING BACK PAIN, RADICULITIS AND OSTEOLYTIC CHANGES. THERE WAS NO FURTHER INFORMATION REPORTED.

    Description of Event or Problem · 0

    THE INFORMATION WAS RECEIVED FROM HEALTH ACRE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR ALIF SPINAL THERAPY. IT WAS REPORTED THAT PATIENT UNDERWENT A ALIF IN (B)(6) 2021 AND HAS PERSISTENT PAIN IN HER LUMBAR SPINE WITH MRI FINDINGS SUGGESTING TO BE CONSISTENT WITH POSSIBLE BMP INFLAMMATORY REACTION. PATIENT IS EXPERIENCING BACK PAIN, RADICULITIS AND OSTEOLYTIC CHANGES. THERE WAS NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778527 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P NEK MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BMP2_ACS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other