BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 11061473 · Received December 22, 2020

    Report

    Report Number
    1030489-2020-01824
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    July 10, 2019
    Report Date
    April 23, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME ADDED 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

    H6: 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. 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

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT AS PER MEDICAL CHART, WORSENING BACK PAIN IS ONGOING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING, CEC ASSESSED THE EVENT AS POSSIBLE TO POSTERIOR LUMBAR FUSION GRAFT, TO INTERBODY FUSION, TO PROCEDURE AND TO THE POSTERIOR FIXATION SYSTEM.

    Additional Manufacturer Narrative · 1

    OTHER ACUPUNCTURE, CBD OIL, WALKER, AND CONTINUE MASSAGE THERAPY. PRODUCT: 1555501070 , LOT NO: 0620556W, QUANTITY: 2 510(K) NO: K113174, UPN: 00643169081284. PRODUCT: 3603514, LOT NO: H5481577, QUANTITY: 2, 510(K) NO:K163375, UPN: 00643169554405 PRODUCT: 55840006545, LOT NO: H5426975, QUANTITY:4, 510(K) NO: K113174, UPN: 00613994971753; PRODUCT: 5540030, LOT NO: H5405786, QUANTITY: 6, 510(K) NO: K113174, UPN: 00613994966476. IT IS UNCLEAR WHETHER THESE DEVICES CAUSED THE SAID ADVERSE EVENT, THIS MDR IS BEING FILED FOR NOTIFICATIONS PURPOSE. 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.

    Description of Event or Problem · 1

    THE INFORMATION WAS RECEIVED FROM A CLINICAL STUDY WITH CLINICAL PATIENT ID: 034511004, REGARDING A PATIENT. THE PATIENT HAD A MEDICAL HISTORY OF STENOSIS WITH DOCUMENTED PRE_OPERATIVE INSTABILITY, FROM L2- S1. THE PATIENT CURRENTLY CONSUMES ALCOHOL, AND A TOBACCO USER. IT WAS REPORTED THAT POST-OP THE PATIENT HAD WORSENING OF BACK PAIN. ASSIGNMENT: 6MG OF RHBMP-2 RANDOMIZATION DATE: 2018-04-20, NUMBER OF LEVELS TO BE TREATED: 2 LEVELS PREGNANT SINCE LAST VISIT 6_WEEKS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT; NO DATE OF VISIT; (B)(6) 2018; PREGNANT SINCE LAST VISIT 3_MONTHS. HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2018. PREGNANT SINCE LAST VISIT 6_MONTHS. HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2018; PREGNANT SINCE LAST VISIT 12_MONTHS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2019; PREGNANT SINCE LAST VISIT 24_MONTHS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2020. IT WAS REPORTED THAT PATIENT COMPLAINS OF MORE PAIN ABOVE AND BELOW FUSION. SITE SERIOUSNESS ASSESSMENT: UADE-N SITE RELATEDNESS ASSESSMENT: THE EVENT IS NOT RELATED TO INTERBODY FUSION, PLF GRAFTING MATERIAL, POSTERIOR FIXATION, SURGICAL CONSTRUCT, AND/OR STUDY PROCEDURE, SURGICAL PROCEDURE. SPONSOR RELATEDNESS ASSESSMENT: THE EVENT IS NOT RELATED TO INFUSE KIT, INTERBODY DEVICE, MGS KIT, PROCEDURE, SURGICAL PROCEDURE AND POSSIBLY RELATED TO MULTIAXIAL SCREWS, RODS , SET SCREWS . INTERVENTIONS: DRUG THERAPY, HOME EXERCISE, OTHER: ACUPUNCTURE, CBD OIL, WALKER, AND CONTINUE MASSAGE THERAPY. OUTCOME STATUS: PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523447 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| O