BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8834609 · Received July 28, 2019

    Report

    Report Number
    1030489-2019-00833
    Event Type
    Injury
    Date Received
    July 28, 2019
    Report Date
    July 28, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY. SOME OF THESE PRODUCTS ARE NOT APPROVED FOR USE IN THE UNITED STATES. SIMILAR DEVICES THAT ARE CLEARED FOR SALE IN THE UNITED STATES HAVE BEEN MENTIONED IN BRACKETS FOR THE RESPECTIVE PRODUCTS: PRODUCT: 1606300500, LOT: 0673499W, QTY: 2. (SIMILAR PRODUCT: 1606200500, 510(K): K131321, UDI# (B)(4); PRODUCT: 55740005550, LOT: H5485399, QTY: 2. (SIMILAR PRODUCT: 55840005550, 510(K): K113174, UDI# (B)(4); PRODUCT: 55740006560, LOT: H13E3163, QTY: 5. (SIMILAR PRODUCT: 55840006560, 510(K): K113174, UDI# (B)(4); PRODUCT: 55740006560, LOT: H5257178, QTY: 5. (SIMILAR PRODUCT: 55840006560, 510(K): K113174, UDI# (B)(4); PRODUCT: 55790015550, LOT: H5400538, QTY: 2. (SIMILAR PRODUCT: 55850015550, 510(K): K170679, UDI# (B)(4); PRODUCT: 55790016550, LOT: H5462625, QTY: 1. (SIMILAR PRODUCT: 55850016550, 510(K): K170679, UDI# (B)(4); PRODUCT: G9010001540, LOT: H5526143, QTY: 1, 510(K): K153589, UDI# ASKU. 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 POSTERIOR SPINAL FUSION AT T8-L2. ON AN UNKNOWN DATE, POST-OP, PATIENT EXPERIENCED INFECTION. HENCE, ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY, IN WHICH WASHING AND DEBRIDEMENT WAS PERFORMED. IT WAS UNKNOWN IF THE ADVERSE EVENT WAS RELATED TO ANY OF THE IMPLANTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628576 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention