BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON BALLAST SPINAL SYSTEM

    MDR report key: 9435491 · Received December 9, 2019

    Report

    Report Number
    1030489-2019-01401
    Event Type
    Injury
    Date Received
    December 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOME TO ADVERSE EVENT: OTHER: PARALYZED. THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# 25740018570; LOT# CA17G088; 510K# K153442; UDI# (B)(4); QTY# 2. PART# 5430520; LOT# 0293711W; 510K# K132328; UDI# (B)(4); QTY# 2. PART# 5530130; LOT# H5368782; QTY# 1. PART# 5530130; LOT# H5380247; QTY# 2. PART# 55740007535; LOT# H5425920; QTY# 2. PART# 7078397; LOT# H5437149; QTY# 1. PART# 779345555; LOT# 0586800W; QTY# 1. PART# G869H021; LOT# 0642575W; 510K# MTF943; UDI# (B)(4); QTY# 1. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE POST-OP, PATIENT HAS BEEN PARALYZED AND UNABLE TO STAND. HENCE ON (B)(6) 2019, THE DECOMPRESSION FIXATION (THE FIXATION THIS TIME, WAS THE FORTH TIME. L1-S2AI) WAS PERFORMED BECAUSE OF THE STENOSIS AND THE THORACIC SPONDYLOTIC MYELOPATHY AT T9-12. THE FIXATION HAD BEEN DONE BEFORE REMAINED THE SAME, AND T9-11 AND L1 WAS CONNECTED WITH THE MRC CLOSE/OPEN VERTICAL CONNECTING CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235283 CD HORIZON BALLAST 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 64 YR Other