BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 11122065 · Received January 6, 2021

    Report

    Report Number
    1030489-2021-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    March 18, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVALUATION METHOD CODE WAS UPDATED BECAUSE THE PRODUCT IS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR ANALYSIS. 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

    THIS PART IS NOT APPROVED FOR MARKET IN THE US. HOWEVER A LIKE DEVICE WITH PART# 8293420, 510K# K031967 AND UPN# (B)(4) IS MARKETED IN THE US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED POST-OP A PLIF PROCEDURE ON L5-S1 IN A PATIENT DIAGNOSED WITH STENOSIS. IT WAS REPORTED THAT THE CAGE BACKED OUT DURING HOSPITALIZATION. A REVISION SURGERY WAS PERFORMED TO REMOVE THE CAGE AND 3 SCREWS ON RIGHT L5, LEFT AND RIGHT S1 WERE REPLACED AND AUTOGRAFT WAS IMPLANTED. THREE SCREWS WERE REPLACED WAS BECAUSE THERE WAS SOME LOOSENESS. HEALTH DAMAGE IN THE PATIENT INCLUDED BACK PAIN AND LOWER EXTREMITY PAIN DUE TO THE CAGE BACKING OUT. AFTER THE OPERATION, THERE SEEMED TO BE NO MALFUNCTION FOR THE CAGE IN PARTICULAR, AND WHY THE CAGE BACKED OUT WAS UNKNOWN ACCORDING TO THE PHYSICIAN'S OPINION. EXPLANTED CAGE WAS HANDED OVER TO THE CUSTOMER AND WILL NOT BE RETURNED. HEALTH DAMAGE WAS REPORTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21051 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G9010001581 0797885W OR 0755121W

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR