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	01/12/2023
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.
Event or Problem Description
On 11-jan-2023 accelus was made aware of a complaint on the remi robotic navigation system.It was reported that a revision surgery was performed on (b)(6) 2023 to remove and replace pedicle screws that were placed inferior to the pedicle during the initial surgery.The initial surgery was a left l4/l5 endo tlif, with linesider mis and remi with o-arm registration.It was reported that during the initial surgery the system was used without connection of the camera to a psis pin as indicated in the remi instructions for use.It was reported that after the initial surgery the patient experienced left side pain upon weight bearing and a ct scan performed to find the left l4 and left l5 pedicle screws were inferior to the pedicles by a similar distance (roughly 5 mm).The patient was then taken back to the or 3 days later and revision of both the left l4 and l5 pedicle screws was performed using stealth navigation and guidewires with linesider mis screws.The revision surgery was completed without issue and no additional patient harm was reported as a result.

• Brand Name: REMI ROBOTIC NAVIGATION SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FUSION ROBOTICS, LLC; 168 centennial parkway; unit 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: 16356078
• Report Number: 3015537048-2023-00001
• Device Sequence Number: 6260802
• Product Code: OLO
• UDI-Device Identifier: 00850026574340
• UDI-Public: (01)00850026574340
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K202184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/10/2023

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?: No
• Device Model Number: PN-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 138 KG
• Patient Ethnicity: Hispanic