BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 14299361 · Received May 6, 2022

    Report

    Report Number
    1030489-2022-00436
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 5, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K NUMBER : THE DEVICE P/N 1556300500 IS SIMILAR TO THE DEVICE MANUFACTURED IN US P/N 1556000500. HENCE, MENTIONED 510K LICENSE NUMBER K111942 IS OF P/N 1556000500. 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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PREOPERATIVE DIAGNOSIS FOR REINFORCEMENT SURGERY DUE TO BILATERAL ROD BREAKAGE. INITIAL SURGERY OR THE PROCEDURE TAKEN WAS T9/S2 FIXATION WITH THE DEGENERATIVE KYPHOSCOLIOSIS IT WAS REPORTED THAT DUE TO BROKEN RODS ON BOTH SIDES, REINFORCEMENT WAS PERFORMED USING A CONNECTOR FROM ANOTHER COMPANY. ALTHOUGH IT IS NOT A BROKEN PIECE, THE BROKEN RODS ON BOTH SIDES ARE LEFT AS IS AND REINFORCEMENT IS PERFORMED WITH CONNECTORS. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE BROKEN RODS ARE STILL IN USE AS THEY ARE. THEY WERE BROKEN BUT WERE NOT SEPARATED INTO PLURAL PIECES/FRAGMENTS. SO, NO FRAGMENTS ARE REMAINING INSIDE THE PATIENT BODY. THE REPORT INDICATES 'BROKEN' BUT THE ACTUAL CONDITION OF THE RODS SEEMS TO BE CLOSER TO 'HAVING CRACKS'. THERE IS NO PLAN TO REMOVE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413763 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1556300500 0691218W

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention