BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE CONTROL¿ SPINAL SYSTEM

    MDR report key: 13041190 · Received December 20, 2021

    Report

    Report Number
    1030489-2021-01565
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 9, 2021
    Report Date
    May 17, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00643169091474
    PMA / PMN Number
    K120368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PRODUCT ID # 3990004 LOT NO. # NM13J005 VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE SHAFT BUT SOME WEAR TO THE INSERTER TIP THREADS. FUNCTIONAL INSPECTION WITH A SAMPLE SHORT INSERTER CONFIRMED THE INSTRUMENT WAS ABLE TO ATTACH AND THREAD INTO THE SHORT INSERTER WITHOUT ANY ISSUES. THE INSTRUMENT APPEARS 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. 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 · 0

    EVALUATION OF THE RETURNED DEVICE WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE. 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 PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR KYPHOSIS. PROCEDURE OR TECHNIQUE USED WAS PLIF. LEVELS IMPLANTED L4/5. IT WAS REPORTED THAT THE SURGEON CHOOSE A CAGE OF A NO PROBLEM SIZE WITH THE TRIAL, BUT WHEN THEY INSERTED THE CAGE, THEY COULD NOT TURN THE INSERTER. ONCE THE SURGEON PULLED OUT THE INSERTER, CAGE WAS TWISTED. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE CAGE WAS TWISTED. INSERTER TIPS WAS SLIGHTLY DEFORMED. SCRATCHES WERE FOUND AT THE TIP, THREADS NEAR THE HANDLE AND BOTTOM OF THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942295 CAPSTONE CONTROL¿ SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 3990004 NM13J005 00643169091474

    Patients

    Seq Age Sex Outcome Treatment
    1 Male