BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 14025015 · Received April 6, 2022

    Report

    Report Number
    1030489-2022-00327
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 8, 2022
    Report Date
    May 16, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A SIMILAR DEVICE CATALOG #1556200500, 510K #K131321 AND UDI #(B)(4) IS MARKETED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    (LOT#). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A ROD AND SCREWS IMPLANTED IN A PATIENT. PROCEDURE PERFORMED IN THE INITIAL SURGERY WAS T9/S2 WAS FIXATED WITH PSF FROM DEGENERATIVE KYPHOSCOLIOSIS. PRE-OP DIAGNOSIS FOR THE REVISION SURGERY WAS BROKEN ROD, SAI SET SCREW DISLODGEMENT ON BOTH SIDES, BILATERAL S1 SCREW AND LEFT SAI SCREW LOOSENING. PROCEDURE PERFORMED IN REVISION SURGERY WAS BOTH SIDES OF S1 SCREWS AND THE LEFT SAI SCREW WERE REPLACED. IT WAS REPORTED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6)2021, BUT DUE TO THE BROKEN ROD, REOPERATION WAS PERFORMED ON (B)(6) 2021. A REOPERATION WAS PERFORMED BECAUSE THE ROD WAS BROKEN AGAIN, THE SET SCREW USED FOR THE SAI SCREW CAME OFF, AND THE SCREW BECAME LOOSE. THE PHYSICIAN REQUESTED THAT THE SCREW HEAD OF THE SAI SCREW THREAD BE CHECKED FOR DAMAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519488 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1556300500 0798097W

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention