BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 12329840 · Received August 17, 2021

    Report

    Report Number
    1030489-2021-01055
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Report Date
    August 17, 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

    Narratives

    Additional Manufacturer Narrative · 1

    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. H6: 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 A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE RODS WERE BROKEN. REOPERATION IS SCHEDULED ON (B)(6) 2021 & SURGEON IS GOING TO USE COMPETITOR'S PRODUCTS. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. DEVICE REMAINS IMPLANTED. OLIF WAS THE PRIMARY SURGERY PERFORMED ON (B)(6) 2016, POSTERIOR FUSION WAS THE SECONDARY SURGERY PERFORMED ON (B)(6) 2016. PATIENT RECOVERED AFTER THE REOPERATION ON 7/30. THE PRODUCT WAS BROKEN BUT THERE WERE NO FRAGMENTS. THE ROD REMAINS IN THE BODY. BROKEN MDT RODS WERE NOT EXPLANTED. PATIENT HAD NO COMPLICATIONS AS A RESULT OF THIS EVENT. A PATIENT WHO WAS FIXED FROM TH10 TO S2AI. ROD WERE BROKEN ON BOTH SIDES BETWEEN L1 / 2. EIGHT ROD CONNECTORS WERE PLACED TO MAKE DUALROD AND THE PROCEDURE WAS COMPLETED. IN THE VIEW OF THE PHYSICIAN, IT IS A PATIENT WHO WAS PERFORMED VCR BETWEEN L1 / 2 AND PLACED CAGE LAST TIME. IT SEEMED THAT THE BONES WERE FUSED, BUT IT WAS A COMMENT THAT THE FIXATION MIGHT HAVE BEEN WEAK BECAUSE IT WAS A PART THAT WAS PERFORMED VCR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229205 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1556300500 0365013W

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention