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

Model Number PN-001

Device Problem Positioning Failure (1158)

Patient Problem Pain (1994)

Event Date 03/21/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 289604356
• Report Number: 3015537048-2022-00001
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00850026574340
• UDI-Public: (01)00850026574340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 118 KG