BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7991057 · Received October 22, 2018

    Report

    Report Number
    3009185973-2018-00281
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    June 7, 2018
    Report Date
    December 18, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    OLO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WAS REPORTED THAT SIX 3D REGISTRATION FAILURES OCCURRED DURING A SURGERY. DHR REVIEW DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. REVIEW OF COMPLAINT HISTORY IDENTIFIED THAT TWO OTHER COMPLAINTS WERE RECEIVED WITHIN THE SIX PAST MONTHS FROM THE EVENT DATE FOR THIS TYPE OF ISSUE ON THIS DEVICE. ONLY ONE OF THEM HAVE THE SAME ROOT CAUSE. ACCORDING TO TECHNICAL INVESTIGATION THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A KNOWN DESIGN DEFECT. IT IS THE SIXTH OCCURRENCE OF THE ISSUE ON THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD SIX FAILURES DURING 3D REGISTRATION. THIS EVENT OCCURRED DURING A MIS PEDICLE SCREW LUMBAR FUSION. THIS EVENT CAUSED A DELAY INFERIOR TO 30 MINUTES AND NO CLINICAL CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED LATE BECAUSE MEDTECH COMPLAINT HANDLING TEAM WAS NOT AWARE OF THIS EVENT IN TIME. THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD SIX FAILURES DURING 3D REGISTRATION. THIS EVENT OCCURRED DURING A MIS PEDICLE SCREW LUMBAR FUSION. THIS EVENT CAUSED A DELAY INFERIOR TO 30 MINUTES AND NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832412 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA ROSA ONE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1