BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 10633989 · Received October 6, 2020

    Report

    Report Number
    1030489-2020-01386
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 16, 2020
    Report Date
    January 13, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    UDI-DI
    00613994803061
    PMA / PMN Number
    K103731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3:PRODUCT ANALYSIS:2990001, LOT#NM12E003. VISUAL EXAM AND MICROSCOPIC EXAM SHOW THAT THE UPPER TAB OF THE INSTRUMENT IS COMPLETELY SHEARED OFF AND THE THREADED INNER SHAFT IS MISSING. THE BROKEN PIECE WAS NOT RETURNED FOR THE ANALYSIS. THIS IS CONSISTENT WITH BEND STRESS OVERLOAD. 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 PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT (MEDICAL HISTORY-DIABETES) HAVING PLIF (POSTERIOR LUMBAR INTERBODY FUSION)(LEVELS IMPLANTED -L3/L5) DUE TO LUMBAR CANAL STENOSIS(LCS). IT WAS REPORTED THAT AFTER THE CAGE WAS INSERTED, THE TIP OF THE INSERTER BROKE DUE TO A SLIGHT TWIST TO ADJUST THE POSITION. THE TIP OF THE INSERTER REMAINED ON THE GRIP PART OF THE CAGE. ALTHOUGH THE CAGE WAS ATTEMPTED TO BE REMOVED, IT WAS DIFFICULT, SO THE CAGE WAS LEFT AS IT WAS. THERE WERE NO PATIENT SYMPTOMS AS A RESULT OF THE EVENT. THE PRODUCT RETURN WAS REQUESTED. THERE WAS A PROCEDURAL DELAY OF LESS THAN 60 MINS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102406 CAPSTONE SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC 2990001 NM12E003 00613994803061

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other