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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported during surgery of a biopsy and litt procedure, the fiducial registration was performed.The biopsy and placement of the litt bolt occurred without incident.During the intraoperative mri scan to begin the litt ablation, surgeon noticed what appeared to be a hemorrhage in the patient's temporal lobe near the laser fiber.Surgeon transitioned the surgery to an open craniotomy to treat the hemorrhage.Reporter is currently unaware at this time of the patient's condition after surgery.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b1; h2; h3; h6 based on the logs and the electrode measurement analysis performed, a trajectory inaccuracy was identified.The actual trajectory was slightly more than 2mm off of the planned entry trajectory at the entry point.The following facts were identified in the logs: the user performed manual bone fiducial registration with the pointer and achieved a passing rms result.The bone fiducial placement was not optimal.The fiducials were not located near the area of interest and were localized to the top of the patient¿s head.Additionally, fiducials 1, 2, and 3 were all located within the same plane.The registration verification was completed with multiple validation points that exceeded the device specification limit.The logs show the software notified the user that ¿a significant error has been detected on this point¿ for the six verification points that were above the threshold.Based on the registration verification screenshots taken by the software, step 1 was performed on a bone fiducial, which is not recommended.The trajectory measurement analysis was performed by the sme (subject matter expert) on the intra op ¿t1 intraop¿ mr exam.The actual trajectory deviated from the planned trajectory, which was above the specification limit of the system.There were no software anomalies identified which would have caused or contributed to the reported event.Bone fiducials registration of the user manual brain application provides the following guidance on bone fiducial placement: ¿the markers must be distributed over the patient's head non-symmetrically and should not be placed in the same plane.It is recommended to place the fiducials near the area of interest and to avoid areas of the head that might move during the procedure.¿ accuracy verification procedure of the brain application user manual recommends that if too high of an error is detected on a point during the verification process, the user should visually check the point and redo registration, if necessary.In this case, the user chose to validate the high errors and proceed with the case, which is not advised.Additionally, accuracy verification procedure of the application user manual provides adequate instructions on performing verification to obtain optimal system performance.A field service engineer (fse) went on-site, for a regular preventative maintenance (pm) approximately 2 weeks after this event.The fse performed a full preventive maintenance, and all tests passed.The unit was confirmed to be in working order.Based on the investigation performed, the root cause for the hemorrhage cannot be determined.While a trajectory inaccuracy and some user errors were identified during the registration and verification process, it cannot be confirmed if these issues caused or contributed to the reported hemorrhage.No issues were found with the rosa unit or rosa software.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.
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.
Event or Problem Description
No further information at the time of this report.

• 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: 19652089
• Report Number: 3009185973-2024-00005
• Device Sequence Number: 6745469
• Product Code: HAW
• UDI-Device Identifier: 03760244034793
• UDI-Public: (01)03760244034793
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 07/22/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/14/2024; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: Other; Hospitalization
• Patient Sex: Unknown