BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10216295 · Received July 1, 2020

    Report

    Report Number
    1030489-2020-00755
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Report Date
    November 27, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3. DEVICE EVALUATION SUMMARY: VISUAL REVIEW CONFIRMS ROD BREAKAGE. SIGNIFICANT FRACTURE SURFACE SMEARING NOTED. OPTICAL AND MICROSCOPIC EXAMINATION OF THE UNDAMAGED AREAS OF THE FRACTURE SURFACES IDENTIFIED A UNEVEN FRACTURE SURFACE THAT IS INDICATIVE OF OVERLOAD. IT WOULD APPEAR THIS ROD MAY HAVE FAILED AFTER THE OTHER ROD FAILED. HOWEVER DUE TO THE POST FRACTURE DAMAGE A ROOT CAUSE CAN NOT BE DETERMINED. 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

    OUTCOMES TO ADVERSE EVENT: PSEUDARTHROSIS. PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG#: 1556200500, 510K#: K131321, UDI#: (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. RADIOGRAPHIC IMAGE REVIEW RESULT: POST-OP X-RAYS FOR LONG SEGMENT FUSION AT MID THORACIC TO PELVIS. ROD FRACTURES ARE PRESENT AT THE LUMBO SACRAL JUNCTION. MULTIPLE INTERBODY GRAFTS ARE PRESENT. THE GRAFT AT THE THORACIC LUMBAR TRANSITION APPEARS ANTERIORLY POSITIONED. THE CONSTRUCT STOPS AT THE APEX OF THORACIC HYPHOSIS AND APPEARS POORLY CONTOURED. FUSION STATUS IS UNKNOWN. 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 UNDERWENT PLIF(POSTERIOR LUMBAR INTERBODY FUSION) AT L5/S DUE TO BONE FUSION AT L5/S WAS NOT ACHIEVED. POST-OP, BOTH THE RODS WERE BROKEN BECAUSE BONE FUSION AT L5/S WAS NOT ACHIEVED. HENCE ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED IN WHICH REPLACEMENT OF THE ROD WAS PERFORMED, AND THE ROD WAS REINFORCED. AND THE SCREW AT TH9 WAS REMOVED DURING THE RE-OPERATION. THERE WERE NO FRAGMENTS OF THE REPORTED PRODUCT REMAINED IN THE PATIENT'S BODY AND NO DELAY IN OVERALL PROCEDURE TIME. PATIENT COMPLICATION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681894 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1556100500 0240779W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R