BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM

    MDR report key: 13017010 · Received December 16, 2021

    Report

    Report Number
    1030489-2021-01553
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 27, 2021
    Report Date
    March 9, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    UDI-DI
    00643169639522
    PMA / PMN Number
    K152277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PART# 2140010 ; LOT# NM16E086- VISUAL INSPECTION CONFIRMED THAT THE THREADED TIP OF INSERTER HAS BEEN SHEARED OFF. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT ANGLED FRACTURE SURFACE. THIS TYPE OF DAMAGE IS CONSISTENT WITH BEND STRESS OVERLOAD. H6: UPDATED EVAL. CODE RESULT AND EVAL. CODE CONCLUSION 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. 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 PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A PIVOX CAGE AND PLATE USING AN INSERTER IN AN L3/4 FUSION FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE INSERTER TIP THREAD BROKE OFF WHILE INSERTING PIVOX CAGE AND PLATE. THE BROKEN TIP SUCCESSFULLY REMOVED AND PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE EVENT TO PATIENT. NO ADDITIONAL SURGERY REQUIRED, ONLY A SHORT DELAY WHEN RETRIEVING THE BROKEN TIP. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915143 PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC 2140010 NM16E086 00643169639522

    Patients

    Seq Age Sex Outcome Treatment
    1 Male