BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 15672067 · Received October 26, 2022

    Report

    Report Number
    1030489-2022-00974
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    April 1, 2021
    Report Date
    October 26, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT SOURCE. COUNTRY: GERMANY. 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

    CITATION: CHRISTOPH SCHOLZ, JAN-HELGE KLINGLER. WASEEM MASALHA, MARC HOHENHAUS, FLORIAN VOLZ. LOANNIS VASILIKOS, ROLAND ROELZ CHRISTIAN SCHELWE AND ULRICH HUBBE. LONG-TERM RESULTS AFTER MULTILEVEL FUSION OF THE CERVICAL SPINE AND THE CERVICOTHORACIC JUNCTION: TO BRIDGE OR NOT TO BRIDGE? WORLD NEUROSURG (2021) 148:E556-564. DOI.ORG/10.1016/ WNEU.2021.01.025. EVENT SUMMARY: IN THE PRESENT STUDY, IT WAS COMPARED THE INCIDENCE OF THESE COMPLICATIONS AND THE REVISION RATES IN MULTILEVEL FUSIONS EXTENDING TO C7 OR T1-T3. IN THE PRESENT SINGLE-CENTER, RETROSPECTIVE COHORT STUDY, PATIENTS WITH MULTILEVEL DEGENERATIVE CERVICAL MYELOPATHY TREATED WITH LAMINECTOMY AND FUSION TO C7 OR T1-T3 FROM 2004 TO 2016 WERE INCLUDED FOR EVALUATION. THE PRIMARY OUTCOME MEASURE WAS RADIOLOGICALLY PROVEN COMPLICATIONS AT THE MOST CAUDAL LEVEL OR THE ADJACENT SPINAL FUSION LEVEL. DESIGN IN THE PRESENT, SINGLE CENTER, RETROSPECTIVE COHORT STUDY, PATIENTS (AGE >18 YEARS) WITH MULTILEVEL DCM WHO HAD UNDERGONE UNDERWENT LAMINECTOMY AND FUSION FROM CO-C3 TO C7 (C7 GROUP) OR TO TI-T3 (TI-T3 GROUP) FROM 2004 TO 2016 WERE ELIGIBLE FOR EVALUATION. FROM 2004 TO 2008, ONLY SPINAL FUSION DOWN TO C7 HAD BEENPERFORMED AT OUR DEPARTMENT. FROM 2008 TO 2012, FUSION DOWN TO C7 AND DOWN TO THE UPPER THORACIC SPINE HAD BEEN PERFORMED. BECAUSE OF OUR INCREASING SUSPICION OF AN INCREASED RISK OF IMPLANT FAILURE AND COMPLICATIONS ASSOCIATED WITH THE CERVICO THORACIC JUNCTION, ONLY SPINAL FUSION BRIDGING THIS SPECIFIC ANATOMIC REGION HAVE BEEN CONDUCTED SINCE 2012. THE EXPERIENCE WITH PATIENTS WITH DCM WHOHAD UNDERGONE LAMINECTOMY AND MULTILEVEL FUSION WERE REPORTED. IN THE PRESENT RETROSPECTIVE STUDY, IT WAS COMPARED THE INCIDENCE OF INSTRUMENT FAILURE AT THE MOST CAUDAL LEVEL OF FUSION, THE INCIDENCE OF ADJACENT SEGMENT DISEASE, AND THE REVISION RATES RESULTING FROM THESE COMPLICATIONS IN PATIENTS WITH MULTILEVEL FUSION FROM CO-C3 EXTENDING TO C7 OR TI-T3. LAMINECTOMY AND MULTILEVEL FUSION FROM CO-CATO C7 OR TO TR-T3 WERE PERFORMED IN 84 PATIENTS WITH DCM.  REPORTED EVENTS: SCREW BREAKAGE 1 TIME WITH THE VERTEX SELECT OUT OF 3 TIMES. IT IS UNKNOWN WHETHER REVISION SURGERY IS PERFORMED OR NOT. THE CAUSE OF INSTRUMENT FAILURE WAS NOT ASSOCIATED WITH THE INSTRUMENTATION BRAND USED AS PER THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2775054 VERTEX RECONSTRUCTION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_SCRW_VTX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown