BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 12616065 · Received October 12, 2021

    Report

    Report Number
    1030489-2021-01270
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    K153589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION- LOT#- H5673902 OR H5697787. IT IS UNKNOWN WHICH LOT NUMBER WAS USED. 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

    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 FIELD REPRESENTATIVE REGARDING PATIENT WITH SCREW DEVIATION INVOLVED IN THE L5 SCREW REPLACEMENT. LEVELS IMPLANTED- L2-L5. IT WAS REPORTED THAT INTRA-OPERATIVELY, TIP OF THE DRIVER BROKE. NO FRAGMENTS LEFT IN THE PATIENT'S BODY. AN ATTEMPT WAS MADE TO REMOVE THE PROLOCK FIRST TO REPLACE THE SCREW, BUT THE GOLDEN SET SCREW OF THE PROLOCK STRIPPED ONE PLACE. THEY REMOVED THE SET SCREWS OF PS ON BOTH SIDES AND REMOVED THE PROLOCK ALONG WITH THE ROD. AFTER THE SCREW REPLACEMENT WAS COMPLETED, THE ORIGINAL IMPLANTED ROD AND PROLOCK WERE RESET, AND WHEN THE PROLOCK WAS FINALLY FIXED WITH A 3.0MM HEX DRIVER ACCORDING TO THE MANUAL MAX, TIP OF THE DRIVER BROKE. THE BROKEN DRIVER TIP WAS REMOVED USING AN AIR TOME. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. EVENT WAS REVISION SURGERY TO EXPLANT THE DEVIATED SCREW. INITIAL SURGERY PROCEDURE WAS PLIF OF 3 INTERVERTEBRAL DISCS AT L2-L5. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2021-SEP-17, RECEIVED ADDITIONAL INFORMATION THAT, IT WAS AN OPERATION FOR REPLACEMENT SINCE THE DEVIATION OF THE SCREW INSERTED IN THE INITIAL OPERATION WAS CONFIRMED. TWO CROSSLINKS WERE USED, ONE OF THEM HAD SET SCREW STRIPPING ON ONE SIDE. THEREFORE, ALL EIGHT SET SCREWS OF THE PEDICLE SCREWS WERE REMOVED, AND THE ROD WAS REMOVED WITH THE CROSSLINK CONNECTED. AFTER REINSERTING (REUSING) THE SCREW ON THE RIGHT SIDE OF L5, REUSING AND PLACING THE ROD AND CROSSLINK, A NEW SET SCREW OF THE PEDICLE SCREW WAS USED AND FINALLY TIGHTENED. ON 2021-SEP-21, RECEIVED ADDITIONAL INFORMATION THAT THE L5 RIGHT SCREW WAS DEVIATED. THE SCREW WAS RE-USED TO TREAT THE PATIENT IN THE REVISION SURGERY. ONE OF THE CROSSLINKS WHICH WAS IMPLANTED IN THE PRIMARY SURGERY HAD SET SCREW STRIPPING ON ONE SIDE DURING REMOVAL IN THE REVISION SURGERY. IT WAS RE-USED TO TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513797 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG G9010001550 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention