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U.S. Department of Health and Human Services

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

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FUSION ROBOTICS, LLC REMI SURGICAL GUIDANCE SYSTEM PRACTICAL NAVIGATION SURGICAL GUIDANCE SYSTEM (PNSGS) Back to Search Results
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.
 
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Brand NameREMI SURGICAL GUIDANCE SYSTEM
Type of DevicePRACTICAL 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 Key14146799
MDR Text Key289604356
Report Number3015537048-2022-00001
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202184
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
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 Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPN-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/19/2022 Patient Sequence Number: 1
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