BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® BALLAST¿ SPINAL SYSTEM

    MDR report key: 18648517 · Received February 6, 2024

    Report

    Report Number
    1030489-2024-00071
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 12, 2024
    Report Date
    February 9, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    UDI-DI
    00643169414914
    PMA / PMN Number
    K153442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: MSB_UNK_SOL_SS_5.5, BRAND NAME: CD HORIZON SOLERA 5.5/6.0, PRODUCT CODE: KWP, 510K: UNKNOWN. PRODUCT ID: MSB_UNK_SOL_SS_5.5, BRAND NAME: CD HORIZON SOLERA 5.5/6.0, PRODUCT CODE: KWP, 510K: UNKNOWN. PRODUCT ID: 55740007535, , UDI#: (B)(4), BRAND NAME: CD HORIZON SPINAL SYSTEM, PRODUCT CODE: KWP, 510K: K202328. 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

    RADIOGRAPHIC IMAGE REVIEW: PLANE CAPTURE AP TLIF CONSTRUCT SHOWS MULTI-LEVEL RECONSTRUCTION FOR PATIENT WITH CORONAL SPINAL DEFORMITY. AP AND LATERAL STANDING SCOLIOSIS FLUORO SHOWS A PROBABLE SCREW FRACTURE AT L5 AND S1, THE ROD IS ALSO DISCONNECTED AT ATLEAST ONE OF THE ILIAC SCREWS. 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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A REVISION SURG ERY FOR PAIN DURING MOVEMENT. IT WAS REPORTED THAT THE LEFT PLUG (S2) DISLODGED AND THE RIGHT PLUG (S2) WAS LOOSE. SCREWS WERE LOOSE ON BOTH SIDES, LEFT F9.5-80MM, RIGHT F9.5-90MM AND WERE RE-INSTALLED. THE S1 PLUGS LOOSENED AND WAS REMOVED TOTALLY. THE PATIENT HAD PAIN DURING MOVEMENT, WAS RE-HOSPITALIZATED AND HAD A REPEAT SURGERY. THERE WAS NO OTHER PATIENT SYMPTOM REPORTED. THERE WERE NO F URTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092385 CD HORIZON® BALLAST¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDTRONIC SOFAMOR DANEK USA, INC 25740018580 UNKNOWN 00643169414914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention "SEE H10...."