BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10113781 · Received June 3, 2020

    Report

    Report Number
    1030489-2020-00568
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    January 1, 2017
    Report Date
    June 3, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOMES TO ADVERSE EVENT: PAIN. THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART#: 7571260; LOT#: UNK; 510K#: K052747; UDI#: (B)(4), QTY# 1. PART#: 7571280; LOT#: UNK, 510K#: K052747, UDI#: (B)(4), QTY# 1. IT IS UNKNOWN WHICH OF THESE RODS WERE BROKEN. 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

    PROCEDURE PERFORMED: (A) L3/4 ANTERIOR LUMBAR INTERBODY FUSION, (B) PRONE POSITION, REVISION OF LONG SEGMENT CONSTRUCT. IT WAS REPORTED THAT POST-OP, IMPLANTED ROD WAS BROKEN AND THE PATIENT WAS SUFFERING FROM EXCESSIVE PAIN. HENCE ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED IN WHICH THE BROKEN ROD WAS REMOVED (PRESUMABLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580676 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R