BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9254469 · Received October 30, 2019

    Report

    Report Number
    1030489-2019-01225
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MDT SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOMES TO ADVERSE EVENT: OTHER: STENOSIS & THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY. THESE PRODUCTS ARE NOT APPROVED FOR SALE IN US; HOWEVER, SIMILAR PRODUCTS THAT ARE APPROVED FOR SALE IN US ARE MENTIONED IN THE BRACKETS '()' AGAINST EACH OF THE BELOW DEVICES: PRODUCT ID: G75446535, LOT: H5424684, QTY: 2. (SIMILAR PRODUCT: 75446535, 510(K): K042025, UDI: (B)(4)). PRODUCT ID: G75446535, LOT: H5465600, QTY: 1. (SIMILAR PRODUCT: 75446535, 510(K): K042025, UDI: (B)(4)). PRODUCT ID: G75446535, LOT: H5488337, QTY: 1. (SIMILAR PRODUCT: 75446535, 510(K): K042025, UDI: (B)(4)). PRODUCT ID: G75447535, LOT: H11H1298, QTY: 2. (SIMILAR PRODUCT: 75447535, 510(K): K042025, UDI: (B)(4)). PRODUCT ID: 779325555, LOT: 0455232W, QTY: 2. (SIMILAR PRODUCT: 778225555, 510(K): K090390, UDI: (B)(4)). PRODUCT ID: 779325555, LOT: 0697712W, QTY: 1. (SIMILAR PRODUCT: 778225555, 510(K): K090390, UDI: (B)(4)). PRODUCT ID: G8699070, LOT: 0638744W, QTY: 1. (SIMILAR PRODUCT: 8699070, 510(K): K981676, UDI: (B)(4)). PRODUCT ID: G8699070, LOT: 0707598W, QTY: 1. (SIMILAR PRODUCT: 8699070, 510(K): K981676, UDI: (B)(4)). PRODUCT ID: G8699090, LOT: 0713851W, QTY: 1. (SIMILAR PRODUCT: 8699090, 510(K): K981676, UDI: (B)(4)). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, 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 (B)(6) 2019, THE PATIENT UNDERWENT FIXATION AT T11-L1 DUE TO L1 VERTEBRAL BODY COLLAPSE. THE SCREWS (IMPLANTED IN THE PREVIOUS SURGERY) BETWEEN L2 AND S1 WERE LEFT IMPLANTED, AND CONNECTION AND EXTENSION WAS PERFORMED USING ROD CONNECTORS. THE ALLEGED PRODUCTS WERE ALSO IMPLANTED DURING THIS SURGERY. ON AN UNKNOWN DATE, POST-OP, STENOSIS OCCURRED AT T10-T11. HENCE, ON (B)(6) 2019, FIXATION WAS EXTENDED TO T9 WITH THE HELP OF ROD CONNECTORS. NO MALFUNCTION WITH ANY OF THE IMPLANTED PRODUCTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050159 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R