BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1030489-2019-01423

    MDR report key: 9470005 · Received December 13, 2019

    Report

    Report Number
    1030489-2019-01423
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    November 14, 2019
    Report Date
    December 13, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS (IMPLANTS AND INSTRUMENTS) WERE USED IN THE SURGERY: PRODUCT ID: CX01B, LOT NO.: UNKNOWN, 510(K): K163032, UDI: (B)(4). PRODUCT ID: OCP220, LOT NO.: UNKNOWN, 510(K): K152057, UDI: (B)(4). PRODUCT ID: KEX152EB-CDS, LOT NO.: UNKNOWN, 510(K): K123771, 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 THAT ON (B)(6) 2019, THE PATIENT UNDERWENT ABLATION AND KYPHOPLASTY AT T11 DUE TO METASTATIC BONE TUMOR, COMPRESSION FRACTURE, VERTEBRAL INSTABILITY AND PLASMACYTOMA. THERE WAS NOTHING WRONG WITH THE PRODUCTS DURING THE SURGERY; AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. EVEN AFTER SEVERAL DAYS POST-OP, PATIENT CONTINUED TO HAVE PAIN. THE TREATING PHYSICIAN THEN RE-IMAGED THE PATIENT WITH CT AND MRI ON (B)(6) 2019. UPON REVIEW OF THESE IMAGES, PATIENT SHOWED SIGNS OF AN EPIDURAL HEMATOMA POSTERIOR TO THE TREATED LEVEL. DUE TO THESE COMPLICATIONS, THE PATIENT HAD A LONGER STAY IN THE HOSPITAL THAN ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264270 NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O