BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11854541 · Received May 20, 2021

    Report

    Report Number
    1030489-2021-00658
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 20, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    COUNTRY: (B)(6). THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 1556200500, 510K# K131321 AND UDI # (B)(4) IS APPROVED FOR SALE 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 · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS OF RIGHT S1 S2AI SET SCREW CAME OFF. IT WAS REPORTED THAT IT WAS A PATIENT WHO WAS PERFORMED TH10-S2AI WITH L3/4/5/S PLIF ON (B)(6) 2017, AFTER THE OPERATION, THE SET SCREW ON THE RIGHT SIDE OF S1 / 2 BACKED OUT (CAME OFF). WHEN OPENED THE WOUND WITH REOPERATION, THE SET SCREW OF L5 ON THE LEFT SIDE ALSO BACKED OUT, THE ROD (5.5MM DIAMETER, COBALT-CHROMIUM) WAS BROKEN AT L5 / S ON THE LEFT SIDE. AS FOR THE SET SCREWS, ALL THREE HAD COMPLETELY BACKED OUT, AND THE ROD WAS SLIGHTLY FLOATING, BUT IT WAS CONTAINED WITHIN THE SCREW HEAD. AS PER PHYSICIAN BONE UNION MIGHT NOT BE ACHIEVED. DURING THE REOPERATION, ALL SCREWS WERE REPLACED AT THREE POSITIONS THAT SET SCREWS HAD BACKED OUT , THE ROD WAS CONNECTED BY MRC ON BOTH SIDES. THE LEFT L5 SCREW WAS REPLACED, THE RIGHT S1 S2 SCREW WAS REPLACED, AND THE ROD WAS CUT BETWEEN THE RIGHT L5 / S AND WAS RE-FIXED ON BOTH SIDES USING WITH MRC. THERE IS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754163 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 1556300500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention