MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA ONE 3.1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.Unique identifier (udi) #: (b)(4).

Event Description

The mri in which the trajectories were planned on and the ct with the bone fiducials were merged (surgeon accepted the merge), registration was performed with an accuracy of 0.31 mm.Clinical representative (cr) was measuring bone thickness and it was noted that the ct was not aligned with mri, when surgeon analyzed the two images they were indeed significantly off.Surgeon assured that this was not the case when the merge was done.The ct image was deleted, surgeon and cr tried merging the ct to the mri again and the images would not align.A new mri was merged to the old mri and the merge was successful.The ct was then merged to the new mri and again the merge was successful.Contactless registration was performed and accepted.After the surgery another ct was taken to confirm electrode placement, the new ct was merged to the old ct and the merge was successful.However, when verifying the trajectories with the placed electrodes it was noted that the electrodes were close to 6mm off.Left side appeared to be more inaccurate than right side.No significant patient impact has been noted.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that an inaccuracy between 4.5mm and 7.5mm is confirmed for all 18 trajectories at the entry point.The registration could have been improved, but is globally accurate.The inaccuracy is most likely due to an undetected movement of the head.A fusion issue was noted, and is probably due to the sagittal acquisition, which is not recommended.

Event Description

The mri in which the trajectories were planned on and the ct with the bone fiducials were merged (surgeon accepted the merge), registration was performed with an accuracy of 0.31 mm.Clinical representative (cr) was measuring bone thickness and it was noted that the ct was not aligned with mri, when surgeon analyzed the two images they were indeed significantly off.Surgeon assured that this was not the case when the merge was done.The ct image was deleted, surgeon and cr tried merging the ct to the mri again and the images would not align.A new mri was merged to the old mri and the merge was successful.The ct was then merged to the new mri and again the merge was successful.Contactless registration was performed and accepted.After the surgery another ct was taken to confirm electrode placement, the new ct was merged to the old ct and the merge was successful.However, when verifying the trajectories with the placed electrodes it was noted that the electrodes were close to 6mm off.Left side appeared to be more inaccurate than right side.No significant patient impact has been noted.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• 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: 14571504
• MDR Text Key: 293143094
• Report Number: 3009185973-2022-00033
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE 3.1
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.5.28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1