ROSA ONE BRAIN
Report
- Report Number
- 3009185973-2023-00021
- Event Type
- Malfunction
- Date Received
- August 16, 2023
- Date of Event
- July 18, 2023
- Report Date
- July 22, 2025
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- UDI-DI
- 03760244033765
- PMA / PMN Number
- K214065
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION OF THE LOG FILES WAS PERFORMED BY THE ZIMMER BIOMET PRODUCT SURVEILLANCE TEAM SUBJECT MATTER EXPERT (SME). RESULTS OF THE LOG FILE INVESTIGATION DID CONFIRM THE REPORTED EVENT. NO SOFTWARE ANOMALIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE REGISTRATION VERIFICATION SCREENSHOTS WERE NOT PROVIDED TO CONFIRM THE ACCURACY OF THE POINTS PLACED. VALIDATION WAS NOT PERFORMED PROPERLY; THUS, IT CANNOT BE CONFIRMED IF THE REGISTRATION WAS COMPLETELY ACCURATE. ALL THE REPORTED ELECTRODE PLACEMENT INACCURACIES ARE CONFIRMED. AN ADJUSTMENT DID OCCUR FOR THE SECOND POST CT SCAN AND A DEVIATION >2MM WAS SEEN. THE DEVIATION ANALYSIS AND NOTES FORM THE SURGEON SUGGESTS THERE WAS HEAD MOVEMENT WITH A CENTER OF ROTATION CLOSE TO THE TEMPORAL RIGHT SIDE WHICH CAN BE A POTENTIAL CAUSE OF THE INACCURACIES SEEN. DEVICE HISTORY RECORDS WERE 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. CORRECTED: G4, UPDATED: G3; H2.
IT WAS REPORTED DURING AN RNS IMPLANTATION SURGERY, AFTER PLACEMENT OF BOTH LEADS (TRAJECTORIES ¿R AMYGDALA¿ AND ¿R HIPPOCAMPUS¿) AN O-ARM CT SCAN WAS TAKEN AND MERGED TO THE REGISTRATION CT. THE ¿R HIPPOCAMPUS¿ LEAD WAS SUPERIOR TO THE PLANNED TRAJECTORY BY ABOUT 5 MM. THE ¿R AMYGLADA¿ LEAD WAS MINIMALLY SUPERIOR AND ANTERIOR TO THE PLANNED TRAJECTORY, BUT WAS DETERMINED TO BE SATISFACTORY. A NEW TRAJECTORY WAS PLANNED TO REPLACE ¿R HIPPOCAMPUS¿. THIS NEW TRAJECTORY (¿TRAJECTORY 1¿) WAS PLANNED INFERIOR TO THE ¿R HIPPOCAMPUS¿ TRAJECTORY. THE LEAD WAS REMOVED AND RE-PLACED AT ¿TRAJECTORY 1¿. ANOTHER O-ARM CT SCAN WAS TAKEN AND MERGED TO THE REGISTRATION CT. THE LEAD WAS ALSO ABOUT 5 MM SUPERIOR TO ¿TRAJECTORY 1¿ AND ABOUT 3 MM SUPERIOR TO ¿R HIPPOCAMPUS.¿ THE SURGEON DETERMINED THAT THE LEAD PLACEMENT WAS SUFFICIENT AND DID NOT NEED FURTHER IMPROVEMENT. SURGEON ALSO NOTED THAT IT WAS POSSIBLE THE HEAD HAD MOVED IN THE CLAMP, AS THERE WAS SOME SLIGHT MOVEMENT TO THE HEAD FIXATION. NO OTHER ISSUES OCCURRED DURING THE PROCEDURE AND THIS RESULTED IN A 30 MINUTE DELAY TO THE CASE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1906651 | ROSA ONE BRAIN | COMPUTER-ASSISTED SURGICAL DEVICE | HAW | MEDTECH SAS | N/A | 3.1.6.276 | 03760244033765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |