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

Catalog Number	ROSAS00203
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation of the log files was performed by the product surveillance team subject matter expert (sme).Results of the log file investigation did confirm the electrode inaccuracies.The following facts were identified in the logs: - fusion: the fusion between exams was reproduced using software version 3.1.6.432.The mri used for the fusion was fuzzy/distorted that could lead to a bad fusion.The merged pre-op and post-op ct exams show a visible shift in the patient¿s head.The user did perform a merge after the implants with a different exam and the fusion did appear better.- registration: manual bone fiducial registration was performed and resulting in passing rms values.The rms error was 0.67mm, which is under the 1.0 mm threshold.- verification: only three of the seven points taken were within the system¿s 2 mm threshold.The software notified the user that ¿a significant error has been detected on this point¿ for all verification points that were above the 2mm threshold.Review of the registration verification screenshots indicate that verification was not performed on the recommended anatomical points.The software notified the user that ¿a significant error has been detected on this point¿ for all verification points that were above the 2mm threshold.The user chose to validate the high errors and proceed with the case.- electrode deviation: the distance between the entry points of the placed electrodes and the planned entry points were analyzed on the post-op ct-bone exam.Both electrodes were displaced greater than 2mm.The deviation analysis suggests there was head movement, as both electrodes appeared to have shifted in the same direction, laterally.There were no software anomalies identified which would have caused or contributed to the reported event.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.The user manual provides information on the methods for registration and warns user that registration error can cause inaccuracies in section 2.4.1 (registration methods).Section 4.6 (registration) details the procedure to perform a registration and verification.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
It was reported post-operatively there was a merge issue.After verifying merge of oam scan, entry points looked wrong, but when remerging the scan to the previous oram spin, it was able to right the merge.The original merge looked normal, but seems it was off.Investigation results confirmed entry point inaccuracy.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 event information available 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: 21293634
• Report Number: 3009185973-2025-00003
• Device Sequence Number: 7585943
• Product Code: HAW
• UDI-Device Identifier: 03760244033765
• UDI-Public: (01)03760244033765
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.6.432
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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
• Patient Sex: Unknown