BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 14158616 · Received April 20, 2022

    Report

    Report Number
    1030489-2022-00372
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 20, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT MARKETED IN US, HOWEVER SIMILAR PRODUCT WITH PRODUCT# 1474000500 AND 510(K)# K091974 IS MARKETED IN 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 · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT L3/4/5 2 INTERVERTEBRAL POSTERIOR LUMBAR INTERBODY FUSION (PLIF) FOR BROKEN ROD BELOW RIGHT L4. IT WAS REPORTED THAT THE ROD UNDER RIGHT L4 WAS BROKEN AND RODS ON BOTH SIDES WERE REPLACED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. PATIENT HAD AN HISTORY OF SMOKING. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REPORTED ROD ABOUT 50CMS WAS CUT INTO TWO PIECES AND USED AS TWO RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266290 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1476100500 0121224W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention