BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9182276 · Received October 11, 2019

    Report

    Report Number
    1030489-2019-01135
    Event Type
    Injury
    Date Received
    October 11, 2019
    Report Date
    October 12, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER: INFECTION, SENSORY AND MOTOR DYSFUNCTION. THE FOLLOWING PRODUCTS WERE REPORTED FOR SERIOUS ADVERSE DEVICE EFFECTS IN THIS CLINICAL STUDY: 1. PRODUCT ID: 7543530, 510(K): K031655, UDI: (B)(4), QTY: 1. 2. PRODUCT ID: 75444530, 510(K): K042025, UDI: (B)(4), QTY: 2. 3. PRODUCT ID: 75445535, 510(K): K042025, UDI: (B)(4), QTY: 1. 4. PRODUCT ID: 75446535, 510(K): K042025, UDI: (B)(4), QTY: 1. 5. PRODUCT ID: 75446545, 510(K): K042025, UDI: (B)(4), QTY: 1. 6. PRODUCT ID: 75446550, 510(K): K042025, UDI: (B)(4), QTY: 2. 7. PRODUCT ID: 75447540, 510(K): K042025, UDI: (B)(4), QTY: 2. 8. PRODUCT ID: 75447545, 510(K): K042025, UDI: (B)(4), QTY: 3. 9. PRODUCT ID: 75447550, 510(K): K042025, UDI: (B)(4), QTY: 3. 10. PRODUCT ID: 75447555, 510(K): K042025, UDI: (B)(4), QTY: 1. ALSO, IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR NOT. 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

    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, AFTER 12 MONTHS FOLLOW-UP, 1 PATIENT REPORTED SENSORY DYSFUNCTION AND 1 PATIENT REPORTED BOTH SENSORY AND MOTOR DYSFUNCTION. SUPERFICIAL INFECTION WAS REPORTED IN 1 PATIENT WHILE 4 PATIENTS REPORTED DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975097 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