ROSA ONE BRAIN
Report
- Report Number
- 3009185973-2025-00009
- Event Type
- Malfunction
- Date Received
- August 5, 2025
- Date of Event
- July 9, 2025
- Report Date
- March 19, 2026
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- UDI-DI
- 03760244034793
- PMA / PMN Number
- K231103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. THE FOLLOWING SECTIONS WERE UPDATED: D4; H2; H3; H6. THE REPORTED EVENT COULD WAS CONFIRMED. TECHNICAL REVIEW AND PHYSICAL EVALUATION: THE LOG FILE INVESTIGATION COULD NOT CONFIRM AN ELECTRODE ENTRY DISCREPANCY >2MM. THE LOGS DID SHOW THE USER ATTEMPTED REGISTRATION NINE TIMES, WITH ONE ATTEMPT GREATER THAN THE SYSTEM'S 1MM THRESHOLD. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS: FUSION: THERE WERE NO ISSUES FOUND WITH THE EXAMS PROVIDED. THE MERGED PRE-OP MRI AND CT EXAMS APPEARED FINE. A POST-OPERATIVE EXAM COULD NOT BE FOUND IN THE PATIENT FOLDER. A CT EXAM TAKEN AFTER ELECTRODE POSITIONING WAS FOUND SHOWING ONLY TWO ELECTRODES PLACED. MERGING THIS CT EXAM TO THE PRE-OPERATIVE CT SHOWED NO DISPLACEMENT. REGISTRATION: MANUAL REGISTRATION WAS PERFORMED WITH A POINTER PROBE NINE TIMES. ONLY ONE REGISTRATION PERFORMED WAS ABOVE THE THRESHOLD OF 1 MM. THE FINAL REGISTRATION WAS ACCEPTABLE (RMS ERROR 0.62). 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. THE USER CHOSE TO VALIDATE THE HIGH ERRORS AND PROCEED WITH THE CASE. REVIEW OF THE REGISTRATION VERIFICATION SCREENSHOTS INDICATE THAT VERIFICATION WAS NOT PERFORMED ON THE RECOMMENDED ANATOMICAL POINTS. ELECTRODE DEVIATION - ENTRY POINT: THE DISTANCE BETWEEN THE ENTRY POINTS OF THE PLACED ELECTRODES AND THE PLANNED ENTRY POINTS WERE ANALYZED ON THE CT-BONE EXAM (¿OARM MID¿). THERE WAS NO CT EXAM PROVIDED FOR THE POST -OPERATIVE VIEW, THUS NOT ALL ELECTRODES WERE CAPTURED. FOR THE ELECTRODES WHICH WERE VISIBLE, THE AVERAGE DEVIATION FOR THE ELECTRODES WERE UNDER THE SYSTEM¿S 2MM SPECIFICATION LIMIT. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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.
IT WAS REPORTED THAT ALL FOUR LEADS WERE ANTERIOR RELATIVE TO THE PLANNED TRAJECTORIES. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 534187 | ROSA ONE BRAIN | MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM | HAW | MEDTECH SAS | 3.1.6.490 | 03760244034793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |