BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11632373 · Received April 8, 2021

    Report

    Report Number
    1030489-2021-00463
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Report Date
    April 26, 2021
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPHIC IMAGE REVIEW RESULT- POST-OP AP X-RAY FOR LUMBAR VERTEBRECTOMY INSTRUMENTATION APPEARS PRESENT POSTERIORLY IN L1-3. THE VERTEBRECTOMY GRAFT HAS TRANSLATED LATERALLY OUT OF THE BONY DEFECT. 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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG#- 55740006545, 510(K)#- K202328 AND UDI#- (B)(4). WAS CLEARED IN THE UNITED STATES. DEVICE MODEL-55790016545 NOT MARKETED IN THE US, BUT IS SIMILAR TO OTHER MARKETED DEVICES. THUS, IT IS REPORTABLE FOR MALF UNCTION, NOT SERIOUS INJURY, ALTHOUGH SURGICAL INTERVENTION DID TAKE PLACE. 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 SYMPTOMS OF VERTEBRAL BODY FRA CTURE INVOLVED IN REPLACEMENT OF VERTEBRAL BODY PROCEDURE. LEVELS IMPLANTED - L2. IT WAS REPORTED THAT DURING USE, THE CAGE BACKED OUT. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. HEALTH DAMAGE IN THE PATIENT WAS REPORTED. PATIENT WAS HOSPITALIZED PROLONG AS THE RESULT OF THIS EVENT. ADDITIONAL TREATMENT/SURGERY WAS SCHEDULED ON (B)(6) 2021 . ON (B)(6) 2021 , RECEIVED ADDITIONAL INFORMATION THAT THE REOPERATION HAD BEEN PERFORMED ON (B)(6) 2021 . POSTERIOR FUSION WAS EXTENDED FROM TH11 TO L4 AND HOOK. FROM ANTERIOR SIDE, T3 WAS REMOVED AND RESRT WITH PILLAR MESH, AND OLIF WAS PERFORMED AT L3 / 4. THE REOPERATION HAD BEEN COMPLETED WITHOUT ANY PROBLEMS. ON 2021-MAR-18, RECEIVED ADDITIONAL INFORMATION THAT, THE SCREWS ON BOTH SIDES OF L1 WERE FOUND TO BE LOOSENED DURING REOPERATION, SO THEY WERE REPLACED WITH NEW SCREWS. PATIENT STATUS AFTER RE-OPERATION REMISSION. ON 2021-MAR-19, RECEIVED ADDITIONAL INFORMATION THERE WERE NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532285 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG 55790016545 H5558769

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R