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

Model Number	N/A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A full analysis of the data logs was performed.The logs confirmed the electrode inaccuracies.There was a shift of the electrode¿s trajectories in the same direction, more inferior than planned.This could indicate head movement, but this cannot be confirmed to be the main contributor of the discrepancies seen.Registration and verification steps were performed per procedure.The registration laser rms was under the threshold.Verification screenshots show the points were taken at the correct anatomical position.The fusions were slightly fuzziness/distortion, which could have contributed to the inaccuracies seen.The pre-op and -post - op ct exams were analyzed, and there appears to be a shift between the two exams.This can be another indicator of head movement.There were no software anomalies identified which would have caused or contributed to the reported event.] device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that there were slight inaccuracies in last couple cases with electrodes appearing inferior to planned trajectories.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: 20524126
• Report Number: 3009185973-2024-00014
• Device Sequence Number: 18418254
• Product Code: HAW
• UDI-Device Identifier: 03760244034793
• UDI-Public: (01)03760244034793
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• 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 Model Number: N/A
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.6.276
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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