BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9390138 · Received November 28, 2019

    Report

    Report Number
    1030489-2019-01348
    Event Type
    Malfunction
    Date Received
    November 28, 2019
    Date of Event
    October 29, 2019
    Report Date
    May 28, 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: D10, H3, H6 H6: PRODUCT ANALYSIS RESULTS: VISUAL AND OPTICAL EXAMINATION IDENTIFIED THE THREADS ARE DAMAGED AND THE HEX OF THE SET SCREW IS STRIPPED. THIS IS CONSISTENT WITH OVERLOAD. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FIXATION AT C2/7 DUE CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OPERATIVELY, THE SET SCREWS WERE PLACED AND ATTACHED TO THE CROSSLINK, AFTER PLACING THE SCREWS AND RODS AT C2-PS (PEDICLE SCREW), C3:PS C4: LMS (LATERAL MASS SCREW), SKIP THE C5, C6:PS, C7:PS. THE PLACEMENT OF THE SET SCREW FOR MAS CROSSLINK AT C6, THEN THE FINAL TIGHTENING AND CROSSLINK PLACEMENT WAS PERFORMED. ALTHOUGH THE SET SCREW INSERTION WAS PERFORMED BUT THE SET SCREWS DID NOT ENTER. EVEN THOUGH THE SURGEON REPLACED EACH SET SCREW WITH THE NEW PRODUCT AND TRIED BUT THE SET SCREW DID NOT ENTER. AFTER CONFIRMING THAT THE NEW SET SCREWS FITTED FIRMLY OUTSIDE THE OPERATIVE FIELD, THE SET SCREWS WERE PLACED AND ATTACHED TO THE CROSSLINK. THE THREADS ARE DAMAGED AND THE HEX HOLE IS ROUNDED OFF. THIS SET SCREW WAS NOT RELATED TO THIS EVENT. FINALLY, CROSSLINK PLACEMENT WAS STOPPED. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT SEEMS THAT SET SCREW WAS NOT RELATED TO THE CAUSE THAT THE ¿MAS CROSSLINK LOCKING SCREW¿ COULD NOT BE PLACED, AND IT MIGHT BE REMOVED F OR THE RECOVERY PROCESS AND SCRATCHED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183639 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5532087

    Patients

    Seq Age Sex Outcome Treatment
    1