BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8467840 · Received March 30, 2019

    Report

    Report Number
    1030489-2019-00353
    Event Type
    Injury
    Date Received
    March 30, 2019
    Report Date
    March 30, 2019
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 1476006200 AND 510K# K121680 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE 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

    IT WAS REPORTED THE PATIENT UNDERWENT POSTERIOR FUSION AT LEVELS T10-T12 AND L1-L3. ON AN UNKNOWN DATE, POST-OP, THE ROD AT L1 BROKE. THE PATIENT DID NOT ACHIEVE FUSION AS WELL. HENCE, A REVISION SURGERY WAS PERFORMED AND THE BROKEN ROD WAS REPLACED WITH A NEW ONE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260915 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention