BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH 3DX

    MDR report key: 13996347 · Received April 4, 2022

    Report

    Report Number
    1030489-2022-00313
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 10, 2022
    Report Date
    August 16, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXB
    UDI-DI
    00613994282668
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 8350294 ; LOT # SW10D060. ANALYSIS SUMMARY: VISUAL AND OPTICAL INSPECTION CONFIRMED THE TIP OF THE PROBE HAS BROKEN. OPTICAL INSPECTION OF THE FRACTURE REVEALED CIRCULAR MATERIAL DISPLACEMENT. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL 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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT, THE TIP OF THE PROBE WAS STUCK IN THE VERTEBRAL BODY. THE SURGEON DEEMED THERE WAS NO RISK OF LEAVING THE FRAGMENT IN PLACE. THE SURGEON DOES NOT HAVE PLAN TO REMOVE THE BROKEN FRAGMENT. THERE HAVE BEEN NO COMPLICATIONS RESULTED AT THIS POINT FROM THE SURGERY. SURGEON WAS USING THE PROBE TO CREATE A PILOT HOLE FOR A PEDICLE SCREW. WHEN THE SURGEON ROTATED THE PROBE ONCE IT WAS IN, THE TIP SNAPPED OFF. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492053 TSRH 3DX PROBE HXB MEDTRONIC SOFAMOR DANEK USA, INC 8350294 SW10D060 00613994282668

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male