BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7972726 · Received October 17, 2018

    Report

    Report Number
    3009185973-2018-00272
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    May 24, 2018
    Report Date
    December 6, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444. (B)(4). IT WAS REPORTED THAT 8 3D REGISTRATION FAILURES OCCURRED DURING THE SURGERY. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF DATA LOGS INDICATES THAT 9 FAILURES AND NOT 8 AS DESCRIBED WHICH OCCURRED DURING THE SURGERY. TECHNICAL INVESTIGATION CONCLUDED THAT THE CAUSE OF THE FAILURES IS A KNOWN DESIGN DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HEIGHT 3D FAILURE OCCURRED DURING A MIS PEDICLE SCREW LUMBAR INFUSION. DEVICE DISPLAYED THE FOLLOWING MESSAGE: IMPOSSIBLE TO RETRIEVE THE REFERENCE POSITION, PLEASE MAKE SURE THE REFERENCE IS VISIBLE. THE REGISTRATION STEPS WERE REPEATED UNTIL THE ISSUE WAS RESOLVED AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT OCCURRED WHILE THE PATIENT WAS UNDER ANESTHESIA AND INCISIONS HAD ALREADY BEEN MADE. THE ISSUE DELAYED THE CASE OF 5-15 MINUTES AS REGISTRATION REQUIRED TO BE RE-DONE. R&D INVESTIGATOR CONFIRMED THAT THE ISSUE ISRELATED TO A KNOWN DESIGN ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359 / K172444.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEIGHT 3D FAILURE OCCURRED DURING A MIS PEDICLE SCREWLUMBAR INFUSION. DEVICE DISPLAYED THE FOLLOWING MESSAGE: "IMPOSSIBLE TO RETRIEVE THE REFERENCE POSITION, PLEASE MAKE SURE THE REFERENCE IS VISIBLE". THE REGISTRATION STEPS WERE REPEATED UNTIL THE ISSUE WAS RESOLVED AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT OCCURRED WHILE THE PATIENT WAS UNDER ANESTHESIA AND INCISIONS HAD ALREADY BEEN MADE. THE ISSUE DELAYED THE CASE OF 5-15 MINUTES AS REGISTRATION REQUIRED TO BE RE-DONE. R&D INVESTIGATOR CONFIRMED THAT THE ISSUE IS RELATED TO A KNOWN DESIGN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813965 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 3.1 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1