BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5309541 · Received December 18, 2015

    Report

    Report Number
    1030489-2015-03486
    Event Type
    Injury
    Date Received
    December 18, 2015
    Date of Event
    November 1, 2015
    Report Date
    November 26, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PRODUCTS WITH MULTIPLE CATALOG NUMBERS WERE IMPLANTED IN THE PROCEDURE INCLUDING: PRODUCT ID: 5530030 QTY(B)(4), PRODUCT ID: 7078396 QTY(B)(4), PRODUCT ID: G8115539 QTY(B)(4), PRODUCT ID: G869H021 QTY(B)(4), PRODUCT ID: 55740004540 QTY(B)(4), PRODUCT ID: 55740005535 QTY(B)(4) PRODUCT ID: 55740005540 QTY (B)(4), PRODUCT ID :55740006535 QTY (B)(4), PRODUCT ID: 55740006540 QTY(B)(4), PRODUCT ID: 55740007540 QTY(B)(4). IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED THE REPORTED EVENT(INFECTION), WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES ONLY. NEITHER THE DEVICE NOR APPLICABLE IMAGING DEVICES WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT PLF SURGERY AT TH10-L4 LEVELS FOR L1 BURST FRACTURE (ALIGNMENT WAS CORRECTED WITH ARI DUE TO MALALIGNMENT AND OBTAIN IMPROVEMENT COMPARING TO PRE-OPERATIVE STATUS). POSTOPERATIVE INFECTION WAS DEVELOPED SO SITE WAS IRRIGATED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837134 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention