BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 11336731 · Received February 17, 2021

    Report

    Report Number
    1030489-2021-00213
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 28, 2021
    Report Date
    September 8, 2021
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    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 · 0

    G3: LIKE DEVICE WITH PART# 6950315, 510K# K052180, K052734 AND UPN 00885074451237 IS APPROVED FOR MARKET IN THE US. H1: AS THE REPORTED PRODUCT IS NOT MARKETED IN US, THE TYPE OF REPORT IS MALFUNCTION. H3: PRODUCT ANALYSIS OF PART # G6950315 ; LOT # H5545915 ANALYSIS SUMMARY: VISUAL AND OPTICAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE THREADS BUT SOME WEAR ON THE BOTTOM NODE OF THE SET SCREW. FUNCTIONAL INSPECTION WITH A SAMPLE BONE SCREW CONFIRMED THE SET SCREW WAS ABLE TO THREAD IN THE HEAD OF THE SCREW WITHOUT ANY ISSUE. UNABLE TO DETERMINE ROOT CAUSE OF SCREW BACKING OUT. 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.

    Additional Manufacturer Narrative · 1

    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 VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH C2 /3 CERVICAL SPONDYLOLISTHESIS SUGGESTED FOR SPINAL THERAPY. PROCEDURE USED WAS C3/4 C4/5 ANTERIOR CERVICAL FUSION AND C2-C5 POSTERIOR FUSION. LEVELS IMPLANTED WAS C2-5. EVENT OCCURRED DURING USE. IT WAS REPORTED THAT THE C2 SET SCREW OF THE PATIENT WHO WAS FIXED ON (B)(6) 2020 BACKED OUT, AND THE CHIEF COMPLAINT OF C2 / 3 CERVICAL SPONDYLOLISTHESIS REOCCURRED. IMPLANT WAS REPORTED TO BE BROKEN, FRAGMENTS REMAINS IN PATIENT. REMOVAL AND REFUSION WERE SCHEDULED ON (B)(6) 2021. DEVICE WILL BE EXPLANTED AND RETURNED. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235066 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G6950315 H5545915

    Patients

    Seq Age Sex Outcome Treatment
    1