BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8415542 · Received March 13, 2019

    Report

    Report Number
    3009185973-2019-00086
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Report Date
    July 3, 2019
    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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PREPARATION OF THE INVESTIGATION IT WAS NOTED THAT THE NOTIFICATION DATE INITIALLY RECORDED WAS INCORRECT. INDEED IT WAS ENTERED AS (B)(6) 2019 BUT THE COMPLAINT DESCRIPTION CLEARLY STATES THAT A COMPANY HARDWARE ENGINEER NOTICED THE ISSUE ON (2019. THE CORRECT EVENT NOTIFICATION DATE IS (B)(6) 2019. IT WAS REPORTED THAT ONE OF THE FOUR IMMOBILIZATION SYSTEM FOOT IS IN THE INCORRECT DIRECTION. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. ACCORDING TO TECHNICAL INVESTIGATION THIS EVENT WAS CAUSED BY A MANUFACTURING ERROR (ASSEMBLY INSTRUCTIONS NOT FOLLOWED), INSUFFICIENT MANUFACTURING INSTRUCTIONS (NO CLEAR EXPLANATION OF THE MOUNTING DIRECTION) AND INSUFFICIENT INCOMING INSPECTION INSTRUCTIONS (PROPER ASSEMBLY WAS NOT VERIFIED).

    Description of Event or Problem · 0

    DURING THE SURGERY, IT WAS NOTICED THAT THE STABILIZATION SYSTEM WAS FUNCTIONAL, HOWEVER, ONE FOOT WAS IN THE WRONG DIRECTION (PARALLEL INSTEAD OF CONVERGING).

    Additional Manufacturer Narrative · 1

    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 SPINE APPLICATION IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA SPINE, CLASSIFIED OLO AND CLEARED UNDER K151511.

    Description of Event or Problem · 1

    DURING THE SURGERY, IT WAS NOTICED THAT THE STABILIZATION SYSTEM WAS FUNCTIONAL, HOWEVER, ONE FOOT WAS IN THE WRONG DIRECTION (PARALLEL INSTEAD OF CONVERGING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211036 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA STABILIZATION SYSTEM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1