BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7888582 · Received September 19, 2018

    Report

    Report Number
    1030489-2018-01257
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 19, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    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. THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 55811014535, 510K# K122433 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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 SPINAL FUSION SURGERY DUE TO HERNIATION AT L3-4. POST-OP, THE PATIENT COMPLAINED OF INFECTION. THE IMPLANTED SCREW GOT LOOSENED DUE TO INFECTION AROUND THE IMPLANT. PATIENT UNDERWENT REVISION SURGERY (TRANSFORAMINAL LUMBAR INTERBODY FUSION) FOR REMOVAL OF IMPLANT AND TO WASH THE AFFECTED PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730499 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13E0205

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R