BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE BRAIN

    MDR report key: 15315047 · Received August 29, 2022

    Report

    Report Number
    3009185973-2022-00038
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    August 1, 2022
    Report Date
    September 20, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K214065
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). COUNTRY OF ORIGIN USA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE ACCURACY OF ELECTRODES PLACEMENT WAS CONFIRMED BY ANALYSIS. NO DEVICE MALFUNCTION WAS FOUND THOUGH ANALYSIS. IT SHOWED THAT THE REGISTRATION WAS ACCURATE ALTHOUGH THE VERIFICATION WAS NOT PERFORMED AS RECOMMENDED PER IFU. THE EXAMS MRI T1 AND THE CT FIDUCIALS WERE NOT ALIGNED DUE TO FUSION WAS NOT ADJUSTED BUT THE ELECTRODES POSITIONING AT ENTRY POINT IS NOT IMPACTED FOR BOTH TRAJECTORIES. THE DEVICE PASSED THE PREVIOUS PREVENTIVE MAINTENANCE AND WAS CONFORMING TO SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN RNS THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO A BLEED. THE TRANSFUSION OCCURRED AFTER THE STEREOTACTIC PORTION AND DURING THE CRANIOTOMY. OTHER THAN THE BLOOD TRANSFUSION THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN RNS THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO A BLEED. THE TRANSFUSION OCCURRED AFTER THE STEREOTACTIC PORTION AND DURING THE CRANIOTOMY. OTHER THAN THE BLOOD TRANSFUSION THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067380 ROSA ONE BRAIN NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTECH SAS N/A 3.1.6.90 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other