BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10103725 · Received May 30, 2020

    Report

    Report Number
    1030489-2020-00562
    Event Type
    Malfunction
    Date Received
    May 30, 2020
    Date of Event
    May 1, 2020
    Report Date
    November 19, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: RADIOLOGICAL IMAGES REVIEW RESULT: MRI/X-RAYS ARE PROVIDED FOR L2-S1 FUSION. AT L2-L3/L3-L4, THE BONE MASS APPEARS SOLID. AN INTERBODY GRAFT IS PRESENT AT L5-S1. FUSION STATUS IS UNKNOWN. A PSEUDO MENINGOCELE IS PRESENT AT THE POSTERIOR CORD/SURGICAL CAVITY ON THE MRI. THE SURGEON DID NOT APPRECIATE THE LOOSE SET SCREW FROM THE DESCRIPTION OF THE EVENT ON THE PROVIDED IMAGING. ADDITIONAL INFORMATION: B5, G1, G2, H10. 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

    H3: ANALYSIS SUMMARY: VISUAL AND OPTICAL INSPECTION OF PART #5430030 AND LOT #H5485139 DID NOT REVEAL ANY DAMAGE TO THE FEMALE TORX HEAD OR THE THREADS OF THE SET SCREW. FUNCTIONAL CHECK WITH A SAMPLE BONE SCREW CONFIRMED THE SET SCREW WAS ABLE TO THREAD INTO THE HEAD OF THE SCREW WITHOUT ANY ISSUE. THERE IS SOME OFF AXIS/ UNEVEN WEAR ON THE BOTTOM SURFACE OF THE SET SCREW FROM THE SEATING OF THE ROD. UNABLE TO DETERMINE ROOT CAUSE OF SET SCREW BACKING OUT. H6 : CODES UPDATED. 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

    FROM THE PRODUCT IMAGE, THE SURFACE OF THE PRODUCT THAT CONTACTS THE ROD WAS DEFORMED AND RUBBED, AND NO PROBLEMS WERE FOUND IN THE THREADS.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440030, 510K # K102555 AND UDI # (B)(4). WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. 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 ADJACENT SEGMENT DISEASE, AND UNDERWENT A SECOND SURGERY. SCREWS OF PETER BREHM, THAT WERE IMPLANTED FROM L2 TO L4 IN THE FIRST SURGERY, WERE REMOVED IN THIS SURGERY AND POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AT L4-L5 AND L5-S1. A NEW CAGE WAS ALSO IMPLANTED DURING THIS SURGERY. ON AN UNKNOWN DATE, THE PATIENT PRESENTED FOR THE THIRD SURGERY WITH PRE-OPERATIVE DIAGNOSIS OF ONLY DECOMPRESSION (FOR LAMINECTOMY AND DURAL REPAIR) BUT LOOSENING OF THE LEFT S1 SET SCREW WAS CONFIRMED DURING THE OPERATION. DECOMPRESSION WAS PERFORMED AT THE LEVELS OF PROXIMAL PART WHERE FIXATION WAS PERFORMED PREVIOUSLY. REPORTEDLY, LOOSENESS OCCURRED AFTER FINAL TIGHTENING WAS PERFORMED. IT SEEMED THAT THE GREY COLOR OF THE SET SCREW HAD BEEN PEELED OFF. ALTHOUGH NO IMPLANT KIT WAS ARRANGED FOR THIS OPERATION, ONLY THE LOOSENED SET SCREW WAS REPLACED USING THE KIT THAT HAD BEEN ARRANGED SEPARATELY. NO INFORMATION REGARDING PATIENT COMPLICATIONS IS AVAILABLE CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567536 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5578321

    Patients

    Seq Age Sex Outcome Treatment
    1