BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    MDR report key: 9709964 · Received February 13, 2020

    Report

    Report Number
    1030489-2020-00171
    Event Type
    Injury
    Date Received
    February 13, 2020
    Report Date
    February 13, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: OUTCOMES TO ADVERSE EVENT: PAIN AND NAUSEA. THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# MSB_UNK_SCREW; LOT# UNK; QTY# (B)(4). PART# MSB_UNK_ROD; LOT# UNK; (B)(4). PART# 9393612; LOT# 21DL; 510K# K172199; UDI# (B)(4), QTY: (B)(4). PART# 9393612; LOT# UK13; 510K# K172199; UDI# (B)(4), QTY: (B)(4). PART# MSB_UNK_SET SCREW; LOT# UNK; QTY: (B)(4). IT IS UNKNOWN WHICH OF THE ABOVE IMPLANTS WERE RESPONSIBLE FOR THE ADVERSE EVENTS. ALSO, IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR NOT. WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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 · 1

    IT WAS REPORTED VIA PATIENT CALL THAT ON AN UNKNOWN DATE, POST-OP, PATIENT WAS HAVING A LOT OF PAIN AND NAUSEA, HE WAS GETTING FEVERISH AND HAD JOINT PAIN. THEY RAN TESTS TO CHECK FOR AUTO-IMMUNE DISEASES AND IT GAVE A FALSE POSITIVE. THIS ALL STARTED APPROX 1 YEAR AFTER THE SURGERY. THE PATIENT WOULD LIKE TO KNOW WHAT METALS ARE IN THE SCREWS AND RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172662 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other