BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 13806076 · Received March 18, 2022

    Report

    Report Number
    1030489-2022-00267
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    February 18, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K202328
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 MEDICAL SAFETY ASSESSES THE REPORTED EVENT OF ¿L2 LEFT PEDICLE WAS CUT OUT¿ AND ITS REPORTED SEVERITY AS NOT RELATED TO THE DEVICE BECAUSE OF THE FOLLOWING: NO DEVICE MALFUNCTION/FAILURE. TTO: THE EVENT OCCURRED INTRAOPERATIVELY. SURGICAL/PROCEDURE RISK: IT WAS REPORTED THAT THE PEDICLE WAS CUT OUT WHEN TORQUE WAS APPLIED AT THE TIME OF THE FINAL TIGHTENING. THE RISK OR CONFOUNDING FACTORS INCLUDED: ELDERLY FEMALE WITH A POSSIBLE HIGH RISK OF LOW BONE QUALITY DUE TO OSTEOPOROSIS/OSTEOPENIA. 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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L2/3 HERNIA. IT WAS REPORTED THAT THE PEDICLE WAS CUT OUT WHEN TORQUE WAS APPLIED AT THE TIME OF THE FINAL TIGHTENING. THE INSTRUMENT/IMPLANT WAS NOT DAMAGED. L1 SCREW EXTENSION PERFORMED AS A RESULT OF THIS EVENT. THERE WAS A DELAY IN OVERALL PROCEDURE TIME. THE IMPLANT WAS NEVER IMPLANTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE SCREW DID NOT MALFUNCTION. NDT PRODUCT MIGHT BE CONTRIBUTED TO CUT THE PEDICLE BECAUSE THE SCREW NEEDS TO BE TIGHTENED STRONGLY IN THE PROCEDURE. THE SURGEON SEEMED NOT TO CONSIDER IT OCCURRED DUE TO THE PRODUCT. PRODUCT WAS DISCARDED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40703 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG 55740004540 H5545266

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention