BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    MDR report key: 8596887 · Received May 9, 2019

    Report

    Report Number
    1030489-2019-00521
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    May 9, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK, INC.
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 5030641, LOT: 46FC, QTY: 1, 510(K) #: K133653, UDI #: (B)(4). PRODUCT ID: 5030641, LOT: 71EJ, QTY: 1, 510(K) #: K133653, UDI #: (B)(4). PRODUCT ID: 3120514, QTY: 6, 510(K) #: K063100, UDI #: (B)(4). PRODUCT ID: 7200037, QTY: 1, 510(K) #: K021461, UDI #: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, 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 THE PATIENT UNDERWENT CERVICAL ANTERIOR FUSION AT C4-C6 DUE TO STENOSIS. ON AN UNKNOWN DATE, POST-OP, THE PATIENT EXPERIENCED SEVERE ITCHING & DISCOMFORT IN THE NECK. ACCORDING TO THE PATIENT, SHE IS ALLERGIC TO TITANIUM. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389505 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other