BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11894997 · Received May 27, 2021

    Report

    Report Number
    1030489-2021-00706
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Report Date
    May 27, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIMILAR PRODUCT WITH PRODUCT# 8699120 AND 510(K)# - K981676 IS MARKETED IN US. THUS, IT IS REPORTABLE FOR MALFUNCTION, NOT SERIOUS INJURY, ALTHOUGH SURGICAL INTERVENTION DID TAKE PLACE. 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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT, IN SURGERY ON (B)(6) 2018, PSF WAS PERFORMED AT L3-S2AI AND TLIF WAS PERFORMED AT L5 / S1. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR SPINAL CANAL STENOSIS. REASON FOR REVISION WAS PSEUDOARTHROSIS OF L5/S1, LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT ROD BREAKAGE OCCURRED ON BOTH SIDES BETWEEN L5 / S1  PROBABLY DUE TO THE INFLUENCE OF L5 / S1 PSEUDOARTHROSIS. IN THE OPERATION THIS TIME, TLIF WAS PERFORMED AGAIN AT L5 / S1 AND ROD R EPLACEMENT WAS PERFORMED. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788701 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G8699120 0637417W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention