BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILLA GROWTH GUIDANCE SYSTEM

    MDR report key: 10014572 · Received April 30, 2020

    Report

    Report Number
    1030489-2020-00487
    Event Type
    Death
    Date Received
    April 30, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 30, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    PGM
    PMA / PMN Number
    K140750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: PGM: GROWING ROD SYSTEM THE FOLLOWING DEVICES WERE USED IN THE SURGERY: 1. PRODUCT ID: 7674425, QTY: 2. 2. PRODUCT ID: 7673425, QTY: 4. 3. PRODUCT ID: 7673025, QTY: 2. 4. PRODUCT ID: 7673525, QTY: 2. 5. PRODUCT ID: 7674025, QTY: 4. 6. PRODUCT ID: 7674500, QTY: 2. 7. PRODUCT ID: 7674501, QTY: 5. 8. PRODUCT ID: 7674502, QTY: 2. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. PRODUCT WAS NOT 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

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SCOLIOSIS; AND UNDERWENT GROWTH GUIDANCE SYSTEM PROCEDURE AT T6-L4. INTRA-OP, THE PATIENT DIED DUE TO BLEEDING. ALL SCREWS, TEMPORARY RODS, AND SETS SCREWS HAD BEEN PLACED PRIOR TO THE EVENT. BLEEDING OCCURRED DURING RESECTION OF THE BONE. BLOOD PRODUCTS WERE GIVEN AS A RESULT OF THIS EVENT. A CODE WAS CALLED AND RESUSCITATION EFFORTS WERE INITIATED. THE PATIENT DIED AFTER ALL THE EFFORTS FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479681 SHILLA GROWTH GUIDANCE SYSTEM PGM MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    0 5 YR Death