BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9792317 · Received March 5, 2020

    Report

    Report Number
    1030489-2020-00259
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    January 9, 2020
    Report Date
    March 24, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G5: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5541198, 510K # K132471 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. ADDITIONAL INFORMATION: B5, D4, G5, H4. 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

    PRE-OP DIAGNOSIS: VERTEBRAL BODY FRACTURE TYPE OF PROCEDURE: POSTERIOR FIXATION THE IMPLANTED LEVEL WAS NOT REMEMBERED CLEARLY. THE DISEASED VERTEBRAL BODY WAS BETWEEN THE IMPLANTED LEVEL. THREE VERTEBRAL BODIES ON THE CRANIAL SIDE WERE FIXED WITH SCREWS AND TWO VERTEBRAL BODIES ON THE CAUDAL SIDE WERE FIXED WITH SCREWS; AND HOOK WAS USED AT THE LOWEST LEVEL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ONLY MONTH AND YEAR VALID. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5541198, 510K # K132471 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH OSTEOPOROTIC VERTEBRAL FRACTURE (OVF) KYPHOSIS; AND UNDERWENT POSTERIOR CORRECTION FIXATION. ON AN UNKNOWN DATE OF (B)(6) 2020, POST-OP, THE IMPLANTED HOOK WAS FOUND STUCK IN THE BONE. THE IMPLANT CONTINUES TO REMAIN IMPLANTED IN THE PATIENT BODY. AS THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, THERE IS NO PLAN TO PERFORM A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255976 CD HORIZON SPINAL SYSTEM NKB WARSAW ORTHOPEDICS NA 0725985W

    Patients

    Seq Age Sex Outcome Treatment
    1