MAUDE Adverse Event Report: FUSION ROBOTICS, LLC REMI SURGICAL GUIDANCE SYSTEM; PRACTICAL NAVIGATION SURGICAL GUIDANCE SYSTEM (PNSGS)

Model Number	PN-001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/21/2022
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 possibly be attributed to patient anatomy.
Event or Problem Description
On 21mar2022 accelus was informed of a complaint on the remi surgical guidance system.It was reported that an initial cortical pedical screw fixation procedure was performed on (b)(6) 2022.Subsequently, the patient returned to the surgeon complaining of left leg pain.Upon 3d imaging review, it was noted that there were misplaced screws during the initial surgery.A revision surgery was performed on (b)(6) 2022 to remove and replace the screws.No additional patient harm was reported as a result of the revision surgery.The patient is reportedly doing well.

• Brand Name: REMI SURGICAL GUIDANCE SYSTEM
• Common Device Name: PRACTICAL NAVIGATION SURGICAL GUIDANCE SYSTEM (PNSGS)
• 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: 14146799
• Report Number: 3015537048-2022-00001
• Device Sequence Number: 19569704
• 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): 04/19/2022

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: 03/21/2022
• Initial Report FDA Received Date: 04/19/2022
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 118 KG