ROSA ONE (JP)
Report
- Report Number
- 3009185973-2025-00012
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- September 22, 2025
- Report Date
- February 27, 2026
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- UDI-DI
- 0376024403
- PMA / PMN Number
- K231103
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A3A; B5; D2B; D4; G1; G3; H1; H3; H6. THE FOLLOWING SECTIONS WERE UPDATED: H6; H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF INFORMATION. MEDICAL RECORDS WERE NOT PROVIDED. INVESTIGATION OF THE LOG FILES WAS PERFORMED BY THE ZIMMER BIOMET PRODUCT SURVEILLANCE TEAM SUBJECT MATTER EXPERT (SME). RESULTS OF THE LOG FILE INVESTIGATION CONFIRMED ELECTRODE ENTRY AND TARGET POINT DISCREPANCY >2MM FOR ONE ELECTRODE. (SEE AI1275989) THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS: ¿ FUSION: THERE WERE NO ARTIFACTS OR DISTORTIONS FOUND WITH THE EXAMS PROVIDED. THE MERGED PRE-OPERATIVE MRI AND CT EXAMS APPEARED FINE. THE FUSION BETWEEN PRE-OPERATIVE AND POST-OPERATIVE CT EXAMS DID SHOW A SLIGHT SHIFT OF THE HEAD. ¿ REGISTRATION: AUTOMATIC LASER REGISTRATION WAS PERFORMED RESULTING IN AN RMS OF 0.423 MM, WHICH IS WITHIN THE 0.85 MM THRESHOLD. ¿ VERIFICATION: THE REGISTRATION VERIFICATION DISTANCE ERRORS FOR ALL VERIFICATION POINTS WERE WITHIN THE SYSTEM¿S 2 MM THRESHOLD. THE REGISTRATION VERIFICATION SCREENSHOTS WERE REVIEWED, AND ALL POINTS WERE TAKEN IN THE RECOMMENDED ANATOMICAL LOCATIONS AS INDICATED BY THE SYSTEM. ¿ ELECTRODE DEVIATION ¿ ENTRY POINT: THE AVERAGE DEVIATION FOR ALL EXCEPT ONE ELECTRODE WERE UNDER THE SYSTEM¿S 2MM SPECIFICATION LIMIT. THE TRAJECTORY 'R HIP HEAD' HAD AN AVERAGE ERROR OF 2.75MM. ¿ ELECTRODE DEVIATION ¿ TARGET POINT: THE AVERAGE DEVIATION FOR ALL EXCEPT ONE ELECTRODE WERE UNDER THE SYSTEM¿S 2MM SPECIFICATION LIMIT. THE TRAJECTORY 'R HIP HEAD' HAD AN AVERAGE ERROR OF 3.01MM. ¿ REVIEW OF ELECTRODE PLACEMENT: ELECTRODE ¿R HIP HEAD¿ SHOWS A CLEAR INFERIOR SHIFT WHEN COMPARING THE PLANNED AND ACTUAL ENTRY POSITIONS. ALL ELECTRODES DEMONSTRATE A SLIGHT ANTERIOR DISPLACEMENT FROM THE PLANNED ENTRY POSITION ON BOTH SIDES OF THE PATIENT; HOWEVER, THE DEVIATION ON THE LEFT SIDE REMAINS WITHIN ACCEPTABLE SPECIFICATIONS. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A3A; B5; B6; D2B; D4; D9; E1; G1; G3; H1; H4; H6. THE FOLLOWING SECTIONS WERE UPDATED: H6; H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF INFORMATION. MEDICAL RECORDS WERE NOT PROVIDED. IT CANNOT BE DEFINITIVELY CONFIRMED IF THE ELECTRODE MISPLACEMENT WAS DUE TO THE HEMORRHAGE NOR WHAT CAUSED THE HEMORRHAGE WITH THE INFORMATION AVAILABLE. INVESTIGATION OF THE LOG FILES WAS PERFORMED BY THE ZIMMER BIOMET PRODUCT SURVEILLANCE TEAM SUBJECT MATTER EXPERT (SME). RESULTS OF THE LOG FILE INVESTIGATION CONFIRMED ELECTRODE ENTRY DISCREPANCY >2MM FOR ONE ELECTRODE. 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. THE FUSION BETWEEN PRE-OPERATIVE POST-OPERATIVE CT EXAMS DID SHOW A SLIGHT SHIFT OF THE HEAD. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING POSSIBLE HEAD/ HEAD HOLDER MOVEMENT. REGISTRATION: AUTOMATIC LASER REGISTRATION WAS PERFORMED AND RESULTING IN AN RMS OF 0.423 MM, WHICH IS WITHIN THE 0.85 MM THRESHOLD. VERIFICATION: THE REGISTRATION VERIFICATION DISTANCE ERRORS FOR ALL VERIFICATION POINTS WERE WITHIN THE SYSTEM¿S 2 MM THRESHOLD. THE REGISTRATION VERIFICATION SCREENSHOTS WERE REVIEWED, AND ALL POINTS WERE TAKEN IN THE RECOMMENDED ANATOMICAL LOCATIONS AS INDICATED BY THE SYSTEM. ELECTRODE DEVIATION - ENTRY POINT: THE AVERAGE DEVIATION FOR ALL EXCEPT ONE ELECTRODE WERE UNDER THE SYSTEM¿S 2MM SPECIFICATION LIMIT. THE TRAJECTORY 'R HIP HEAD' HAD AN AVERAGE ERROR OF 2.75MM. REVIEW OF ELECTRODE PLACEMENT: ELECTRODE ¿R HIP HEAD¿ HAS A VISIBLE SHIFT INFERIORLY WHEN COMPARING THE PLANNED POSITION AND ACTUAL POSITION ON THE POST-OPERATIVE CT EXAM. THERE WAS NO SHIFT SEEN ON THE LEFT SIDE OF THE PATIENT¿S HEAD. HOWEVER, ON THE RIGHT SIDE, THE TWO ELECTRODES DID SHOW INFERIOR MOVEMENT. AS PER COMPLAINT DESCRIPTION, THE HEMORRHAGE OCCURRED UNDER THE SKULL AND BASED ON THE PLANNING, THE ENTRY POINT WAS ON THE SKULL. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO INDICATE THAT THE ROSA MALFUNCTIONED OR CONTRIBUTED TO THE ADVERSE EVENT. THE CAUSE OF THE BLEEDING CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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.
(B)(4). G2: FOREIGN: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
IT WAS REPORTED THAT FOLLOWING DEEP ELECTRODE IMPLANTATION, POSTOPERATIVE CT DEMONSTRATED A SUBARACHNOID HEMORRHAGE. THE SURGERY WAS COMPLETED USING THE UNIT. PREOPERATIVE PLANNING REPORTEDLY SHOWED NO OBVIOUS VASCULAR INTERFERENCE, AND THE CAUSE WAS UNKNOWN. THE SURGEON COMMENTED THAT THE HEMORRHAGE MAY HAVE BEEN RELATED TO PLACEMENT OF AN ELECTRODE TOWARD THE LEFT AMYGDALA AND POSSIBLE TRACTION ON THE SYLVIAN FISSURE DURING TRACT CREATION. THE PATIENT HAD NO DECREASE IN CONSCIOUSNESS AND WAS MANAGED WITH BLOOD PRESSURE CONTROL AND OBSERVATION WITHOUT DRUG ADMINISTRATION. A REPEAT CT PERFORMED APPROXIMATELY 4 HOURS POSTOPERATIVELY DEMONSTRATED NO HEMORRHAGE EXPANSION, AND A SUBSEQUENT PROGRESS CHECK APPROXIMATELY 2 DAYS LATER AGAIN NOTED NO EXPANSION WITH THE PATIENT IN GOOD HEALTH. AN ANGIOGRAM WAS PERFORMED APPROXIMATELY 3 DAYS POSTOPERATIVELY, AND THE PLAN WAS TO REMOVE THE ELECTRODE IF NO ANEURYSM WAS IDENTIFIED. THE PATIENT REMAINED IN GOOD HEALTH WITH NO DECREASE IN CONSCIOUSNESS, AND NO HEMORRHAGE EXPANSION WAS OBSERVED ON SERIAL CT EVALUATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT FOLLOWING DEEP ELECTRODE IMPLANTATION, A SUBARACHNOID HEMORRHAGE WAS IDENTIFIED ON POSTOPERATIVE CT. SUBSEQUENTLY, PREOPERATIVE PLANNING REPORTEDLY SHOWED NO OBVIOUS VASCULAR INTERFERENCE, AND THE SURGEON COMMENTED THE HEMORRHAGE WAS POSSIBLY RELATED TO ELECTRODE PLACEMENT INTO THE LEFT AMYGDALA AND/OR TRACTION ON THE SYLVIAN FISSURE DURING TRACT CREATION. BLOOD PRESSURE CONTROL WAS INITIATED, AND A FOLLOW-UP CT PERFORMED APPROXIMATELY 4 HOURS POSTOPERATIVELY SHOWED NO HEMORRHAGE EXPANSION. THE PATIENT WAS MONITORED WITHOUT DRUG ADMINISTRATION, AND A PROGRESS REPORT APPROXIMATELY 2 DAYS LATER AGAIN NOTED NO BLEEDING EXPANSION AND THE PATIENT REMAINED IN GOOD HEALTH. AN ANGIOGRAM WAS PERFORMED ON APPROXIMATELY THE THIRD POSTOPERATIVE DAY, AND IF NO ANEURYSM WAS IDENTIFIED, ELECTRODE REMOVAL WAS SCHEDULED. THE PATIENT REMAINED IN GOOD HEALTH WITHOUT DECREASED CONSCIOUSNESS, AND SERIAL IMAGING SHOWED NO HEMORRHAGE EXPANSION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT AFTER DEEP ELECTRODE IMPLANTATION, CT SHOWED SUBARACHNOID HEMORRHAGE. THERE WAS NO OBVIOUS VASCULAR INTERFERENCE ON PLANNING, AND THE CAUSE WAS UNKNOWN. THE SURGERY WAS COMPLETED UTILIZING THE ROSA UNIT. THE PATIENT WAS IN GOOD HEALTH WITH NO DECREASE IN CONSCIOUSNESS, AND WAS EVALUATED AGAIN IN 4 HOURS WITH BLOOD PRESSURE CONTROL BY CT. THE PATIENT WAS FOLLOWED UP WITHOUT ANY DRUG ADMINISTRATION. THE DOCTOR INFORMED THE PATIENT THAT THERE WAS NO HEMORRHAGE EXPANSION ON CT 4 HOURS AFTER SURGERY. HE ALSO RECEIVED A PROGRESS REPORT THAT THERE WAS NO BLEEDING EXPANSION 2 DAYS LATER AND THE PATIENT WAS IN GOOD HEALTH. AN ANGIOGRAM WAS PERFORMED ON THE THIRD POSTOPERATIVE DAY, AND IF NO ANEURYSM IS FORMED, THE ELECTRODE IS SCHEDULED TO BE REMOVED. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2004908 | ROSA ONE (JP) | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTECH SAS | 3.1.6.490 | 0376024403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |