BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9172873 · Received October 9, 2019

    Report

    Report Number
    1030489-2019-01136
    Event Type
    Injury
    Date Received
    October 9, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: DEEP INFECTION. THE FOLLOWING PRODUCTS WERE REPORTED FOR ADVERSE DEVICE EFFECTS IN THIS CLINICAL STUDY: PRODUCT ID: 75446545, 510(K): K042025, UDI: (B)(4), QTY: 1. PRODUCT ID: 75446550, 510(K): K042025, UDI: (B)(4), QTY: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NO. OF PATIENTS: 21 (MALE: 13, FEMALE: 08); MEAN AGE: 60.6 YEARS, MEAN WEIGHT: 76.5 KG; MEAN HEIGHT: 172.1 CM SOCIAL HISTORY: CURRENT SMOKER: YES (4 PATIENTS), NO (5 PATIENTS), UNKNOWN (12 PATIENTS) PRIMARY DIAGNOSIS: SPINAL TUMOR (18 PATIENTS), M. KAHLER (3 PATIENTS) GROUPS DISCUSSED IN THIS STUDY: LEG_V006: MULTI-AXIAL OR SAGITTAL ADJUSTING SCREW LEG_V013: FIXED ANGLE SCREW IT WAS REPORTED IN THE CLINICAL STUDY TITLED ¿CLINICAL OUTCOMES AND SAFETY OF LEG_V006 AND LEG_V013 WITH MINIMUM 12 MONTHS FOLLOW UP" THAT 21 PATIENTS WERE DIAGNOSED WITH SPINAL TUMOR FROM JAN 2014 TO JAN 2018. POST-OPERATIVELY, SCREW MALPOSITION AND DEEP INFECTION WAS REPORTED FOR 2 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966777 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other