BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    MDR report key: 8118908 · Received November 30, 2018

    Report

    Report Number
    1030489-2018-01594
    Event Type
    Injury
    Date Received
    November 30, 2018
    Report Date
    November 30, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: TITLED- MINIMIZING SPINE AUTOFUSION WITH THE USE OF SEMICONSTRAINED GROWING RODS (SCGR) FOR EARLY ONSET SCOLIOSIS (EOS) IN CHILDREN BY CHARLES BOUTHORS, MD. .AGE AT EVENT: AGE DISTRIBUTION WAS 1.5 TO 10.5 YEARS, WITH AN AVERAGE AGE OF 8.1 YEARS. SEX: GENDER DISTRIBUTION WAS 16 FEMALES AND 12 MALES. DATE OF EVENT: UNKNOWN. 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 IN THE LITERATURE TITLED ¿MINIMIZING SPINE AUTOFUSION WITH THE USE OF SEMICONSTRAINED GROWING RODS (SCGR) FOR EARLY ONSET SCOLIOSIS (EOS) IN CHILDREN¿ THAT THE ROD HAD FRACTURED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960747 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other