BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 12613262 · Received October 12, 2021

    Report

    Report Number
    1030489-2021-01263
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 17, 2021
    Report Date
    April 19, 2022
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    K170679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3:PART # (B)(6). LOT # H5543049 VISUAL AND OPTICAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE THREADS OF THE FEMALE TORX OF THE SCREW. THE BREAK OFF TABS OF THE SCREW HAVE BEEN REMOVED. FUNCTIONAL CHECK WITH A SAMPLE SET SCREW CONFIRMED THE SET SCREW TO WAS ABLE TO ENGAGE AND THREAD CORRECTLY. THE SCREW APPEAR TO FUNCTION AS INTENDED. NO FAULT FOUND. 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. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH ADJACENT SEGMENT DISEASE AT L2-5 FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW DID NOT FIT IN THE L3 LEFT SCREW, THE TAB WAS BROKEN OFF, AND THE THREAD ON THE SCREW HEAD SIDE WAS SHAVED, SO THEY REPLACED THE SCREW. THE SET SCREW HAD A DAMAGED THREAD, AND THE TIP WAS DEFORMED AND SCRATCHED. THE SCREW TABS BROKEN, SCRATCHED ON THE EDGES AND BOTTOM OF THE SCREW NECK / CROWN / TORX HOLES, AND THE SCREW HEAD THREADS. AN ATTEMPT WAS MADE TO INSERT THE SET SCREW INTO THE REPORTED SCREW, BUT IT COULD NOT BE SET. THERE WAS LESS THAN 60 MIN DELAY IN OVERALL PROCEDURE TIME. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517237 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55750018545 H5543049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown