BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9284032 · Received November 6, 2019

    Report

    Report Number
    1030489-2019-01281
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 8, 2019
    Report Date
    May 19, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: PRODUCT ANALYSIS RESULTS: VISUAL AND OPTICAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE FEMALE HEX OR THE THREADS OF THE SCREW. THERE IS NO SIGNS OF OFF AXIS SEATING THAT COULD CONTRIBUTE TO THE SCREWS BACKING OUT. FUNCTIONAL CHECK WITH A SAMPLE ROD AND BONE SCREW CONFIRMED THE SET SCREW WAS ABLE TO THREAD INTO THE BONE SCREW WITHOUT ANY ISSUE. UNABLE TO DETERMINE ROOT CAUSE OF SCREWS BACKING OUT. 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.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 6950315, 510K# K052180 AND UPN (B)(4) IS APPROVED FOR MARKET IN THE US. PRODUCT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    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 CERVICAL THORACIC POSTERIOR FIXATION DUE TO PARALYSIS. POST-OPERATIVELY, THE C2 SET SCREW BACKED OUT . RE-OPERATION OF SCREW REPLACEMENT WAS PLANNED TO BE PERFORMED. THE PATIENT WAS NOT STRONG MOVING BECAUSE THE PATIENT HAD BEEN IN AN EXTERNAL FIXATION STATE. THERE WAS A DELAY OF MORE THAN 60 MINS IN PROCEDURE TIME AS A RESULT OF THIS ALLEGED EVENT. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IN REVISION SURGERY,THE WOUND SITE CLEANING WAS PERFORMED BECAUSE THE INFECTION WAS DEVELOPED AFTER REMOVING THE IMPLANT. THERE WAS NO MALFUNCTION WITH THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079807 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5483091

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability