BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON ASTUTE SPINAL SYSTEM

    MDR report key: 11676743 · Received April 16, 2021

    Report

    Report Number
    1030489-2021-00500
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 29, 2021
    Report Date
    August 3, 2021
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    NQP
    PMA / PMN Number
    K191066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D10 : INITIAL REPORT SECTION D INFORMATION REFERENCES THE MAIN DEVICE. OTHER RELEVANT DEVICE TO THE EVENT INCLUDE: PEEK ROD 1608451100 6.0 X6.9MM STR 100MM, LOT # ZD82, PMA / 510(K) # K191066. H3: PRODUCT ANALYSIS: PART # (B)(4), LOT # ZD82, VISUAL AND MICROSCOPIC INSPECTION CONFIRMED THE ROD HAS BROKEN IN MULTIPLE PIECES. THE ROD SURFACE SHOWS EVIDENCE OF THE ROD SEATING IN THE TULIP PORTION OF THE BONE SCREW. MICROSCOPIC INSPECTION OF THE FRACTURE DID NOT REVEAL ANY DAMAGE THAT COULD CONTRIBUTE TO THE ROD BREAKING. IT APPEARS THE MATERIAL OF THE ROD WAS OVERLOADED AND THE PORTIONS OF THE RODS WHERE THE SCREW WAS SEATED APPEAR TO HAVE BEEN OVERTIGHTENED CAUSING THE MATERIAL TO CRACK. PRODUCT ANALYSIS: PART # (B)(4), LOT # ZD82, VISUAL AND MICROSCOPIC INSPECTION CONFIRMED THE ROD HAS BROKEN IN MULTIPLE PIECES. THE ROD SURFACE SHOWS EVIDENCE OF THE ROD SEATING IN THE TULIP PORTION OF THE BONE SCREW. MICROSCOPIC INSPECTION OF THE FRACTURE DID NOT REVEAL ANY DAMAGE THAT COULD CONTRIBUTE TO THE ROD BREAKING. IT APPEARS THE MATERIAL OF THE ROD WAS OVERLOADED AND THE PORTIONS OF THE RODS WHERE THE SCREW WAS SEATED APPEAR TO HAVE BEEN OVERTIGHTENED CAUSING THE MATERIAL TO CRACK. 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

    DEVICE EVALUATED BY MFR: 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 WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ROD AND SCREW EXPLANT. IT WAS REPORTED THAT RODS HAD AN INTENDING BREAKING POINT AT EACH LEVEL OF THE SET SCREWS. ONE ROD WAS ALREADY BROKEN IN SITU, THE SECOND ONE WAS BREAKING OFF DURING THE RE-MOVEMENT OUT OF THE SCREWHEADS.  PRE OP DIAGNOSIS WAS REVISION SPONDYLODESES L3-S1, DECOMPRESSION L4-L5, SPONDYLODESES-EXTENSION L2-S1. SURGEON COMMENTED THAT MATERIAL OF THE PEEK ROD LOOKS BRITTLE. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575059 CD HORIZON ASTUTE SPINAL SYSTEM POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION NQP MSD DEGGENDORF MFG 1608451100 ZD82

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention SEE H10.