BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8766868 · Received July 8, 2019

    Report

    Report Number
    1030489-2019-00731
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 19, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: IN ADDITION TO THE ALREADY REPORTED SCREW, THE FOLLOWING PRODUCTS (NOT MARKETED IN US) WERE ALSO USED IN THE SURGERY. THE SIMILAR DEVICES THAT ARE APPROVED FOR SALE IN US ARE MENTIONED IN BRACKETS '()' ACROSS EACH PRODUCT: 1. PRODUCT ID: G75446540, LOT #: H5335872, QTY: 1 (SIMILAR PRODUCT: 75446540, 510(K): K042025, UDI: (B)(4)) 1. PRODUCT ID: G75446545, LOT #: H5421024, QTY: 4 (SIMILAR PRODUCT: 75446545, 510(K): K042025, UDI: (B)(4)) 1. PRODUCT ID: G75447540, LOT #: H5384637, QTY: 2 (SIMILAR PRODUCT: 75447540, 510(K): K042025, UDI: (B)(4)) 1. PRODUCT ID: G75447545, LOT #: H5341353, QTY: 2 (SIMILAR PRODUCT: 75447545, 510(K): K042025, UDI: (B)(4)) 1. PRODUCT ID: G869H021, LOT #: 0630612W, QTY: 1 (SIMILAR PRODUCT: 869-021, 510(K): K040962, UDI: (B)(4)) ALTHOUGH IT IS UNKNOWN WHETHER THE ABOVE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE REPORTING THE ABOVE PRODUCTS FOR NOTIFICATION PURPOSE. ADDITIONAL INFORMATION: B5, D4, H4, 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.

    Description of Event or Problem · 0

    NO MALFUNCTION WAS REPORTED FOR THE SCREW. SINCE T12 VERTEBRAL BODY (WHICH WAS THE MOST UPPER LEVEL VERTEBRAL BODY THAT WAS TREATED) COLLAPSED, EXTENSION OF FUSION WAS PERFORMED TO A FURTHER UPPER LEVEL.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 75446540, 510K #K042025 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. ALTHOUGH IT IS UNKNOWN WHETHER THIS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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 POSTERIOR LUMBAR FUSION AT T12-L4. ON AN UNKNOWN DATE, POST-OP, T12 VERTEBRAL BODY COLLAPSED. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO EXTEND FUSION TO T8. THE PATIENT'S ISSUE HAS NOW BEEN REPORTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562661 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5335868

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention