BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 16437702 · Received February 24, 2023

    Report

    Report Number
    1030489-2023-00110
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    April 12, 2022
    Report Date
    February 24, 2023
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INAMULLAH KHAN, SCOTT L. PARKER, HANSEN BOW, AHILAN SIVAGANESAN, JACQUELYN S. PENNINGS, BYRON F. STEPHENS II, ANTHONY M. STEINLE, RISHABH GUPTA AND CLINTON J. DEVIN. " CLINICAL AND COST-EFFECTIVENESS OF LUMBAR INTERBODY FUSION USING TRITANIUM POSTEROLATERAL CAGE (VS. PROPENSITY-MATCHED COHORT OF PEEK CAGE)" SPINE SURG RELAT RES 2022; 6(6): 671-680, DX.DOI.ORG/10.22603/SSRR.2021-0252. PATIENT AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT EVENT DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE. BRAND NAME IS UNKNOWN. PRODUCT IDENTIFIERS ARE UNKNOWN. PMA/510(K)# IS UNKNOWN. 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. 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

    SUMMARY: SURGICAL MANAGEMENT OF DEGENERATIVE LUMBAR SPINE DISORDERS IS EFFECTIVE AT IMPROVING PATIENT PAIN, DISABILITY, AND QUALITY OF LIFE; HOWEVER, OBTAINING A DURABLE POSTEROLATERAL FUSION AFTER DECOMPRESSION REMAINS A CHALLENGE. INTERBODY FUSION TECHNOLOGIES ARE VIABLE MEANS OF IMPROVING FUSION RATES IN THE LUMBAR SPINE, SPECIFICALLY VARIOUS GRAFT MATERIALS INCLUDING AUTOGRAFT, STRUCTURAL ALLOGRAFT, TITANIUM, AND POLYETHER ETHER KETONE. THIS STUDY ASSESSES THE EFFECTIVENESS OF TRITANIUM POSTEROLATERAL CAGE IN THE TREATMENT OF DEGENERATIVE DISK DISEASE OVER PROPENSITY-MATCHED COHORT OF PEEK CAGE. A TOTAL OF 228 PATIENTS WHO UNDERWENT ELECTIVE LUMBAR INTERBODY FUSION SURGERY FOR DEGENERATIVE DISK DISEASES AND HAD COMPLETED 12-MONTH FOLLOW-UP WERE INCLUDED IN THE STUDY. THE TRITANIUM PL CAGE IS MANUFACTURED BY STRYKER. SO TOTAL OF 114 PATIENTS USED MEDTRONIC CAGES WHICH ARE CONSIDERED HERE. DEMOGRAPHIC, RADIOGRAPHIC, CLINICAL AND TREATMENT DATA WERE COLLECTED AND ANALYZED. THIS STUDY REPRESENTS THE FIRST REAL-WORLD COMPARISON OF A POROUS TITANIUM CAGE TO A PEEK CAGE IN THE ELECTIVE SURGICAL MANAGEMENT OF DEGENERATIVE LUMBAR DISC DISEASES. REPORTED EVENTS: A TOTAL OF 114 PATIENTS WHO UNDERWENT ELECTIVE LUMBAR INTERBODY FUSION SURGERY FOR DEGENERATIVE DISK DISEASES AND HAD COMPLETED 12-MONTH FOLLOW-UP USING PEEK CAGE THE COMPLETION RATE FOR 12-MONTH FOLLOW-UP RATE WAS RECORDED AT 81%. PREOPERATIVELY, APPROXIMATELY 74% (N=84) WERE AMBULATORY WITHOUT ANY ASSISTANCE AND 24% (N=28) NEEDED DEVICE ASSISTANCE FOR AMBULATION, WHEREAS 2% (N=2) WERE NON-AMBULATORY THE PEEK COHORT HAD HIGHER PROPORTION OF PATIENTS WITH LONGER DURATION OF SYMPTOMS (P=0.007) AND HAD HIGHER MEAN NUMBER OF INVOLVED VERTEBRAE (2.68 VS. 1.92, P=0.029) COMPARED TO THE TRITANIUM COHORT. SIXTEEN PERCENT (N=18) OF PATIENTS UNDERWENT REVISION SURGERY FOR PREVIOUS DISCECTOMY OR DECOMPRESSION SURGERY. PRIMARY DIAGNOSIS FOR THE PATIENT WAS DEFORMITY/SCOLIOSIS, HERNIATED DISC, SPONDYLOLISTHESIS AND STENOSIS. AVG NUMBER OF LEVELS INVOLVED WAS 2.68. THE RADIOGRAPHIC IMAGES REVEALED AROUND 40.2% INCIDENCES OF SUBSIDENCE OF THE CAGES IN THE PEEK COHORT. AT 90 DAYS MORBIDITY, THERE WAS 2 CASE OF WOUND DEHISCENCE/SURGICAL SITE INFECTION, 2 CASES OF HARDWARE REVISION, 1 CASE OF NEW NEUROLOGIC DEFICITS AND 2 CASE OF MEDICAL (UNRELATED TO SPINE). WHILE RETURNING TO OPERATING ROOM (OR) , THERE WAS TOTAL 4 CASES IN WHICH ONE CASE EACH WAS DUE TO WOUND AND INFECTION AND 2 CASES RELATED TO HARDWARE. CONCLUSION: RESULTS INDICATED THAT THE POROUS TITANIUM CAGE IS AN EFFECTIVE ALTERNATIVE TO THE PREVIOUSLY USED PEEK CAGE IN TERMS OF PROS, SURGICAL SAFETY, AND RADIOLOGICAL PARAMETERS OF SURGICAL SUCCESS. THE TRITANIUM COHORT SHOWED BETTER ODI SCORES, HIGHER FUSION RATES, LOWER SUBSIDENCE, AND LOWER INDIRECT COSTS ASSOCIATED WITH SURGICAL MANAGEMENT, WHEN COMPARED TO THE PROPENSITY-MATCHED PEEK COHORT. THE RESULTS OF THIS STUDY ARE UNIQUE AND CAN INFORM SURGEONS¿ DECISIONS FOR INTERBODY CAGE MATERIAL IN THE TREATMENT OF LUMBAR DEGENERATIVE DISC DISEASES. PATIENT MEDICAL HISTORY INCLUDED HYPERTENSION, ARTHRITIS, DIABETES, COPD AND OSTEOPOROSIS. SEE THE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059265 UNKNOWN INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_CAGE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female