BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 10046013 · Received May 12, 2020

    Report

    Report Number
    1030489-2020-00519
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    February 11, 2020
    Report Date
    March 9, 2021
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    UPDATED INFORMATION RECEIVED ON 05-MAR-2021: OUTCOME STATUS: RECOVERED/RESOLVED OUTCOME DATE: (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    OTHER: PAIN. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 2991022, LOT: H5127666(X1), UDI: (B)(4), 510K: K073291 PRODUCT ID: 5540030, LOT: H5501967(X1), H5502072(X3), UDI: (B)(4), 510K: K113174. PRODUCT ID: 55840007540, LOT: H5439129(X4), UDI: (B)(4), 510K: K113174. PRODUCT ID: 1553201035, LOT: 0754123W (X2), UDI: (B)(4), 510K: K113174. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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

    PRE OP DIAGNOSIS: INSTABILITY WITH SECONDARY DIAGNOSIS- STENOSIS PROCEDURE PERFORMED: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (OPEN OR MINI OPEN) LEVELS IMPLANTED: L4-L5 IT WAS REPORTED VIA A CLINICAL STUDY THAT ON (B)(6) 2020, POST OP, PATIENT SUFFERED INCREASED LOW BACK PAIN LIKE PRE-OP. IT IS INCREASING WHILE WALKING AND PHYSICAL ACTIVITY. DRUG THERAPY WAS GIVEN TO DECREASE ACTIVITY. SEVERITY OF THE AE (ADVERSE EVENT): MODERATE. IN RESPONSE TO THE AE: INSTRUCTED TO DECREASE ACTIVITY. AS PER THE INVESTIGATOR RELATEDNESS ASSESSMENT, THE EVENT IS NEITHER RELATED WITH PROCEDURES AS WELL THE CONSTRUCT/PRODUCTS. BUT AS PER SPONSOR¿S ASSESSMENT EVENT IS POSSIBLY RELATED WITH THE STUDY PROCEDURE, NOT RELATED WITH THE GRAFTING MATERIALS AND UNLIKELY RELATED WITH THE CONSTRUCT. OUTCOME OF THIS AE: NOT RECOVERED/NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512180 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG 2991022 H5127666

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other