BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 8389424 · Received March 5, 2019

    Report

    Report Number
    1030489-2019-00221
    Event Type
    Injury
    Date Received
    March 5, 2019
    Report Date
    March 5, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALTHOUGH IT IS UNKNOWN WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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 UNDERWENT BKP SURGERY AT T12. POST-OP, "OVF" OCCURRED AT T12 AND PATIENT COMPLAINED OF PAIN PAIN. A FRACTURE WAS SUSPECTED TO OCCUR INSIDE THE INJURED VERTEBRAL BODY. THE PATIENT HAD NOT BEEN HOSPITALIZED AND WAS DURING FOLLOW-UP OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183228 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other