BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9174356 · Received October 10, 2019

    Report

    Report Number
    1030489-2019-01142
    Event Type
    Injury
    Date Received
    October 10, 2019
    Report Date
    October 10, 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

    OTHER: INFECTION, SENSORY AND MOTOR DYSFUNCTION. THE FOLLOWING PRODUCTS WERE USED IN THE 28 PATIENTS COVERED IN THIS CLINICAL STUDY: PRODUCT ID: 7543535, 510(K): K031655, UDI: (B)(4), QTY: 1. PRODUCT ID: 7543540, 510(K): K031655, 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: 2. PRODUCT ID: 75446535, 510(K): K042025, UDI: (B)(4), QTY: 5. PRODUCT ID: 75446540, 510(K): K042025, UDI: (B)(4), QTY: 13. PRODUCT ID: 75446545, 510(K): K042025, UDI: (B)(4), QTY: 13. PRODUCT ID: 75446550, 510(K): K042025, UDI: (B)(4), QTY: 5. PRODUCT ID: 75446555, 510(K): K042025, UDI: (B)(4), QTY: 1. PRODUCT ID: 75447535, 510(K): K042025, UDI: (B)(4), QTY: 1. PRODUCT ID: 75447540, 510(K): K042025, UDI: (B)(4), QTY: 6. PRODUCT ID: 75447545, 510(K): K042025, UDI: (B)(4), QTY: 9. PRODUCT ID: 75447550, 510(K): K042025, UDI: (B)(4), QTY: 6. PRODUCT ID: 75447555, 510(K): K042025, UDI: (B)(4), QTY: 3. 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

    PATIENT DEMOGRAPHICS: NO OF PATIENTS: 28; GENDER: (MALE:22; FEMALE:06); AGE(MEAN): 53.9 YEARS, WEIGHT(MEAN): 86.3KGS; HEIGHT(MEAN): 179 CMS; CURRENT SMOKER: YES (00 PATIENT), NO (10 PATIENTS), UNKNOWN (18 PATIENTS) DIAGNOSIS- FRACTURE (25 PATIENT), BURST FRACTURE (3 PATIENT) GROUPS DISCUSSED IN THIS STUDY: LEG_V004: MULTI-AXIAL OR SAGITTAL ADJUSTING SCREW LEG_V011: FIXED ANGLE SCREW IT WAS REPORTED PER A CLINICAL STUDY TITLED ¿CLINICAL OUTCOMES AND SAFETY OF LEG_V004 AND LEG_V011 WITH MINIMUM 12 MONTHS FOLLOW UP" THAT 28 PATIENTS WERE DIAGNOSED WITH FRACTURE AND BURST FRACTURE FROM JAN 2014 TO JAN 2018. THESE PATIENTS WERE TREATED WITH LEG_004 DURING THE ABOVE MENTIONED TIMEFRAME. 1 PATIENT TREATED WITH LEG_V011 ALSO RECEIVED LEG_V004. POST-OPERATIVELY, AFTER 12 MONTHS FOLLOW-UP, 3 PATIENT REPORTED SENSORY DYSFUNCTION, 1 MOTOR DYSFUNCTION AND 6 PATIENT REPORTED BOTH SENSORY AND MOTOR DYSFUNCTION. ONE PATIENT SUFFERED FROM DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970289 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 54 YR Other