BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE CONTROL¿ SPINAL SYSTEM

    MDR report key: 12588964 · Received October 7, 2021

    Report

    Report Number
    1030489-2021-01244
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    August 20, 2021
    Report Date
    February 2, 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 OF PART # 3990004 ; LOT # NM15D028 ANALYSIS SUMMARY: VISUAL AND OPTICAL INSPECTION CONFIRMED THE THREADS AT THE TIP OF THE THREADED INSERTER SHAFT HAVE BEEN STRIPPED/DAMAGED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE MISALIGNMENT AND ENGAGEMENT PROCESS OF THE SHORT INSERTER INSTRUMENT. 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

    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 · 1

    INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING L2-S2AI-PSF, L4/5-PLIF. THE PRE-OPERATIVE DIAGNOSIS WAS MENTIONED AS LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT, THE SHORT INSERTER WAS FOUND TO HAVE A CRACK AT THREAD AND THE OTHER INSERTER SHAFTS WERE NOT ATTACHED TO IMPLANT DUE TO THREAD DAMAGE. THE INSERTER TIP WAS DEFORMED. THE INSERTER SHAFT WAS STRIPPED AT THE TIP AND SCRATCHES AND BURRS WERE FOUND AT THREADS ON HANDLE SIDE. THE OTHER INSERTER HAD SCRATCHES AT TIP THREADS AND SCRATCHES AND STRIPPING FOUND AT THREADS. THE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT. PATIENT MEDICAL HISTORY INCLUDES HT, DM, CEREBRAL INFARCTION, TWO-SIDED TKA, DVT. THERE WAS NO HEALTH DAMAGE IN PATIENT REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488815 CAPSTONE CONTROL¿ SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 3990004 NM15D028 00643169091474

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female