MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN; MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient came back after surgery with a post op bleed.Post op scans were merged the to the patient plan to check the trajectories and 2 out of 4 of the trajectories were significantly off.The bleed came from a trajectory that did have an accurate entry/trajectory point.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed and the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h6 investigation of the log files was performed by the subject matter expert (sme).Results of the log file investigation did not confirm electrode entry discrepancies nor inaccurate registration.The logs did show target point discrepancies.The following facts were identified in the logs: ¿ fusion: there was slight fuzziness or distortion found in the mri that could have contributed to the inaccuracies seen.The fusion between pre-operative post-operative ct exams did not show any significant shift of the head/head holder.¿ registration: automatic laser registration was performed and resulting in a rms of 0.841221 mm, which is extremely close to the threshold.¿ verification: the distance errors for all verification points were within the system¿s threshold.The registration verification screenshots were reviewed, and all points were taken in the recommended anatomical locations as indicated by the system.There was a small space between the skin and the red dot for the left temple.The red circle should touch the skin (white part) in at least one of the views.A review of the automatic scanning shows the 3d mesh was visible and the points appear to be distributed evenly on different plans.Therefore, the registration verification result was correct but not optimal.¿ electrode deviation - entry point: the average deviation for entry points for all electrodes were under the system¿s specification limit.Based off this information, no inaccuracy was found at any entry point.¿ electrode deviation - target point: there were inaccuracies with the target points, deviation greater than the threshold.A review of the target points did show a significant shift on two electrodes on the patient's right side.There was about 7.38mm directional error along the axis for the target point of ¿r frontal'.There was about 3.62 mm directional error along the axis for the target point of ¿rcm¿.According to the surface matching registration of the user manual, the recommended positions for the initial points should be scanned manually using the laser beam oriented perpendicularly to the skin surface.The points should be marked at the surface of the skin on invariant areas or the fiducials.The laser rms was 0.841221 mm, which is extremely close to the threshold.Prior to the case, the pdm was onsite to assist and observed that the optical distance sensor (ods) sick box ¿moving average¿ value was 256 (the factory default setting) instead of 8, confirming the reported event.The value was manually changed back to 8, and they proceeded with the case.Additional investigation was conducted.It was concluded that there was no technical malfunction with the robot.Device history records were reviewed and no discrepancies related to the reported event were found.There were no confirmed electrode entry points nor registration inaccuracies.The average deviation for entry points for all electrodes were under the system¿s specification limit.The registration was performed correctly, but the verification result was not optimal.There is no evidence to indicate that the rosa malfunctioned or contributed to the adverse event.The cause of the bleeding cannot be determined with the information available.The patient had the implants removed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Corrected: g4.Updated: g3; h2.

• Brand Name: ROSA ONE BRAIN
• Common Device Name: MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 19706458
• Report Number: 3009185973-2024-00006
• Device Sequence Number: 7751703
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)190906
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K214065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.6.432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 01/16/2025; 07/22/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 01/24/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown