MAUDE Adverse Event Report: FUSION ROBOTICS, LLC REMI ROBOTIC NAVIGATION SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PN-001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.However, the device was evaluated in the field by a qualified accelus representative and found to be fully functioning.The preliminary assessment determined that the system likely functioned as intended and the screw positioning issue could have been attributed to use of a third party drill guide with the remi system (and in the case of the l4 screw, it was revised during the original procedure without the remi system and still ended up in a less than ideal location).While the system was used without connection of the camera to a psis pin, there is no indication that this caused or contributed to the issue and is just noted as an off label use of the system.
Event or Problem Description
On 21-apr-2022 accelus was made aware of a complaint on the remi robotic navigation system that occurred during an initial 3-level pedicle screw fixation procedure on (b)(6) 2022.It was reported that on intra-operative imaging the surgeon confirmed that the left l4 screw was misplaced.The screw was removed and replaced without using the remi system.Postoperatively, the patient reported experiencing bilateral leg pain.Upon imaging review, it was noted that the left l4 screw was medialized.Imaging also showed inferior (a lower down position) pedicle screw placement of all screws in the construct.The surgeon reported that at the time of the surgery he felt the placing of the left l4 screw felt "off" even after he replaced it and additionally noted fighting soft tissue on placement of all 6 screws in the construct.During the initial surgery the surgeon used a drill guide provided by a third party.The surgeon reported that he now believed that the lack of teeth on the drill guide did not allow it to seat well on the bone causing skive and the resulting screw misplacement.It was also reported that the system was used without connection of the camera to a psis pin as indicated in the remi instructions for use, however, there appears to be no link to this off label use and the resulting placement issues.A revision surgery was performed on (b)(6) 2022 to remove and replace all the screws.No additional patient harm was reported as a result of the revision surgery.The patient is reportedly doing well.

• Brand Name: REMI ROBOTIC NAVIGATION SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FUSION ROBOTICS, LLC; fusion robotics, llc; 168 centennial parkway, 170; louisville CO 80027
• Manufacturer (Section G): FUSION ROBOTICS, LLC; 168 centennial parkway; unit 170; louisville CO 80027
• Manufacturer Contact: brad clayton ; 168 centennial parkway; unit 170; louisville, CO 80027 ; 7203888100
• MDR Report Key: 14464166
• Report Number: 3015537048-2022-00002
• Device Sequence Number: 11891060
• Product Code: OLO
• UDI-Device Identifier: 00850026574340
• UDI-Public: (01)00850026574340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PN-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female