BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8193490 · Received December 24, 2018

    Report

    Report Number
    1030489-2018-01693
    Event Type
    Injury
    Date Received
    December 24, 2018
    Report Date
    December 24, 2018
    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

    MULTIPLE PRODUCTS WERE INVOLVED IN THE EVENT. TWO SCREWS OF THE MENTIONED PART AND LOT INFO LED TO THE EVENT. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER , A LIKE DEVICE WITH PART# 55811014540, 510K# K122433 AND UPN (B)(4). HAS BEEN CLEARED FOR US. 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

    PRE-OP DIAGNOSIS FOR THE SURGERY- SECOND LUMBAR SPINAL METASTASIS PROCEDURE USED: TOTAL EN BLOC SPONDYLECTOMY (TES), T12/L1-L3/4 POSTERIOR SPINAL FUSION IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CASE THAT T2 PLACEMENT WAS PERFORMED AFTER TES, AND SCREW FUSION WAS PERFORMED WITH 2-2. THE SCREWS WERE FOUND LOOSE AND RHEXIS OCCURRED AT POSTERIOR SIDE DUE TO WHICH THE KYPHOSIS BECAME WORSE AND THE POSITION OF T2 WAS ALSO DANGEROUS. PATIENT UNDERWENT REVISION AND THE SCREWS WERE REPLACED. PATIENT HAD A PAIN IN THE BACK. DURING THE OPERATION, SOMETHING LIKE SPINAL FLUID LEAKED. NO OTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033657 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA14C099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R