BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9150601 · Received October 3, 2019

    Report

    Report Number
    1030489-2019-01110
    Event Type
    Injury
    Date Received
    October 3, 2019
    Report Date
    October 3, 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

    THE FOLLOWING PRODUCTS WERE USED IN THE 40 PATIENTS COVERED IN THIS CLINICAL STUDY: PRODUCT ID: 75444530, 510(K): K042025, UDI: (B)(4), QTY: 1. PRODUCT ID: 75445535, 510(K): K042025, UDI: (B)(4), QTY: 3. PRODUCT ID: 75445540, 510(K): K042025, UDI:(B)(4), QTY: 8. . PRODUCT ID: 75445545, 510(K): K042025, UDI: (B)(4), QTY: 1. PRODUCT ID: 75446535, 510(K): K042025, UDI: (B)(4), QTY: 7. PRODUCT ID: 75446540, 510(K): K042025, UDI: (B)(4), QTY: 36. PRODUCT ID: 75446545, 510(K): K042025, UDI: (B)(4), QTY: 78. PRODUCT ID: 75446550, 510(K): K042025, UDI: (B)(4), QTY: 40. PRODUCT ID: 75446555, 510(K): K042025, UDI: (B)(4), QTY: 3. PRODUCT ID: 75447535, 510(K): K042025, UDI: (B)(4), QTY: 3. PRODUCT ID: 75447540, 510(K): K042025, UDI: (B)(4), QTY: 20. PRODUCT ID: 75447545, 510(K): K042025, UDI: (B)(4), QTY: 66. PRODUCT ID: 75447550, 510(K): K042025, UDI: (B)(4), QTY: 91. PRODUCT ID: 75447555, 510(K): K042025, UDI: (B)(4), QTY: 25. PRODUCT ID: 7041870, 510(K): K040962, UDI: (B)(4), QTY: 1. PRODUCT ID: 7041880, 510(K): K040962, UDI: 00885074032221, QTY: 2. PRODUCT ID: 7041890, 510(K): K040962, UDI: (B)(4), QTY: 4. PRODUCT ID: 7543535, 510(K): K031655, UDI: (B)(4), QTY: 1. PRODUCT ID: 7543540, 510(K): K031655, UDI: 00721902857997, QTY: 1. PRODUCT ID: 7543635, 510(K): K031655, UDI: (B)(4), QTY: 2. PRODUCT ID: 7543640, 510(K): K031655, UDI: (B)(4), QTY: 8. PRODUCT ID: 7543645, 510(K): K031655, UDI: (B)(4), QTY: 4. PRODUCT ID: 7543650, 510(K): K031655, UDI: (B)(4), QTY: 4. PRODUCT ID: 7543740, 510(K): K031655, UDI: (B)(4), QTY: 2. PRODUCT ID: 7543745, 510(K): K031655, UDI: (B)(4), QTY: 6. IT IS UNKNOWN WHICH OF THE ABOVE IMPLANTS WERE RESPONSIBLE FOR THE ADVERSE EVENTS. 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

    PATIENTS DETAILS: TOTAL PATIENTS: 40 (MALE:15, FEMALE:25); MEAN WEIGHT: 73.2 KGS; MEAN AGE: 57.6 YEARS; MEAN HEIGHT: 167.8 CMS CURRENT SMOKER: YES (12 PATIENTS), NO (26 PATIENTS), UNKNOWN (02 PATIENTS) PRIMARY DIAGNOSIS: DEGENERATIVE LUMBAR SCOLIOSIS (34 PATIENTS), SCHEUERMANN HYPERKYPHOSIS (05 PATIENTS), M. BECHTEREW (01 PATIENT) GROUPS DISCUSSED IN THIS STUDY: LEG_V003: MULTI-AXIAL OR SAGITTAL ADJUSTING SCREW LEG_V010: FIXED ANGLE SCREW IT WAS REPORTED PER A CLINICAL STUDY TITLED ¿CLINICAL OUTCOMES AND SAFETY OF LEG_V003 AND LEG_V010 WITH MINIMUM 12 MONTHS FOLLOW UP" THAT 40 PATIENTS WERE DIAGNOSED WITH SPINAL DEFORMITY FROM JAN-2014 TO JAN-2018. PATIENTS WHO RECEIVED LEG_V010 (6 PATIENTS) ALSO RECEIVED LEG_V003 AND WERE THEREFORE COMBINED IN THIS REPORT. POST-OPERATIVELY, 3 PATIENTS SUFFERED FROM MINOR INFECTION, 5 PATIENTS SUFFERED FROM DEEP INFECTION, AND 1 PATIENT HAS FRACTURED VERTEBRA. AFTER 12 MONTHS OF FOLLOW-UP, 1 PATIENT REPORTED SENSORY DYSFUNCTION AND 3 PATIENTS REPORTED MOTOR DYSFUNCTION, BACK PAIN WAS REPORTED IN 11 PATIENTS AND LEG PAIN WAS REPORTED IN 11 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944700 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 57 YR Other