BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH 3DX

    MDR report key: 13140383 · Received January 3, 2022

    Report

    Report Number
    1030489-2022-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2022
    Date of Event
    December 9, 2021
    Report Date
    May 17, 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
    FL, 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

    PRODUCT ANALYSIS PRODUCT ID:8350294 LOT NO.: KH21B060 VISUAL OBSERVATION REVEALS THAT THE TIP OF THE PROBE HAS BEEN BENT FROM WHAT APPEARS TO BE OVERLOAD. 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 · 0

    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 SCOLIOSIS, DEGENERATION THORACIC AND LUMBAR SPINE. PROCEDURE OR THERAPY PERFORMED WAS OLIF. IT WAS REPORTED THAT THE TIP OF THE THREADED SHAFT BROKE OFF DURING IMPLANTATION OF A CAGE AT THE DISC SPACE OF L3/4 DURING AN OLIF. DURING THE POSTERIOR PORTION OF THE SURGERY, THE TIP OF THE INSTRUMENT BENT. THE CAGE WAS IMPLANTED SUCCESSFULLY. THE TIP OF THE THREADED SHAFT REMAINS INSIDE THE IMPLANT IN THE PATIENT. NOTHING HAPPENED TO THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO ADDITIONAL SURGERY IS PLANNED. THE SHAFT TIP WAS SAFELY SECURED INSIDE THE IMPLANT. THERE WAS NO WAY TO REMOVE IT.

    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 SCOLIOSIS, DEGENERATION THORACIC AND LUMBAR SPINE. PROCEDURE OR THERAPY PERFORMED WAS OLIF. IT WAS REPORTED THAT THE TIP OF THE THREADED SHAFT BROKE OFF DURING IMPLANTATION OF A CAGE AT THE DISC SPACE OF L3/4 DURING AN OLIF. DURING THE POSTERIOR PORTION OF THE SURGERY, THE TIP OF THE INSTRUMENT BENT. THE CAGE WAS IMPLANTED SUCCESSFULLY. THE TIP OF THE THREADED SHAFT REMAINS INSIDE THE IMPLANT IN THE PATIENT. NOTHING HAPPENED TO THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO ADDITIONAL SURGERY IS PLANNED. THE SHAFT TIP WAS SAFELY SECURED INSIDE THE IMPLANT. THERE WAS NO WAY TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356911 TSRH 3DX PROBE HXB MEDTRONIC SOFAMOR DANEK USA, INC 8350294 KH21B060 00613994282668

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male