BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH 3DX

    MDR report key: 10910264 · Received November 26, 2020

    Report

    Report Number
    1030489-2020-01696
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    November 6, 2020
    Report Date
    April 9, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXB
    UDI-DI
    00613994282668
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PART# (B)(4), LOT# SW11C598: VISUAL OBSERVATION REVEALS THAT THE TIP OF THE PROBE HAS BEEN BROKEN OFF FROM WHAT APPEARS TO BE OVERLOAD. HARDNESS REVEALS THAT THE PROBES ARE THE PROPER HARDNESS. THIS IS CONSISTENT WITH BEND STRESS OVERLOAD. H6: UPDATED EVAL. CODE METHOD AND EVAL. CODE RESULT POST 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. 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 A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A PROBE FOR A POSTERIOR INSTRUMENTED FUSION. IT WAS REPORTED THAT THE PROBE BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THE PATIENT DID COME IN CONTACT WITH THE REPORTED PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS DEGENERATIVE SPINE. THE LEVELS IMPLANTED WERE L2-L4. THERE WAS TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS THE TIME IT TOOK TO REMOVE THE BROKEN PORTION OF THE INSTRUMENT FROM THE BONE. APPROXIMATELY 1 HOUR. THERE WAS A DELAY OF 60 MINUTES DUE TO THIS. THE PRODUCT WILL BE REPLACED BY A MEDTRONIC PRODUCT IN THE FUTURE. THE PATIENT'S MEDICAL HISTORY INCLUDED PREVIOUS SPINAL SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374605 TSRH 3DX PROBE HXB MEDTRONIC SOFAMOR DANEK USA, INC 8350294 SW11C598 00613994282668

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other