BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7538280 · Received May 23, 2018

    Report

    Report Number
    1030489-2018-00732
    Event Type
    Injury
    Date Received
    May 23, 2018
    Report Date
    May 23, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    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

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 869-021, 510K# K040962 AND (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FIXATION AT (B)(4). POST-OP, THE TIP OF THE CRANIAL SIDE ROD TOUCHED WITH THE SKIN AND IT LOOKED LIKE A DECUBITUS ULCER. THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CRANIAL SIDE ROD WAS CUT WITH A GIANT CUTTER AND THE WOUND WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379640 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0328242W

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention