MAUDE Adverse Event Report: MIGHTY OAK MEDICAL FIREFLY; PATIENT-SPECIFIC PEDICLE SCREW GUIDE

Model Number	FF-101-XX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Nervous System Injury (2689); Unspecified Nervous System Problem (4426)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary & conclusion: review of dhr did not identify and deviations or abnormalities.Review of complaint history did not identify any additional complaints on this item for loss of motors.The 20adan spine assembly a1 cad file was downloaded and inspected.Visual inspection of the guide identified 6 patient contacting locations (2 fixation screws, 2 legs, and 2 distal extensions) to guide 3 screws (t7 l&r and t7 l hemi).Inspection of the planned trajectories identified that both t7 screws were against the medial wall of the pedicle but not breaching.All screws were planned in an acceptable location per the work order fulfillment process.Inspection of the cad files for the guides & screws found that the guide was conforming.The bone model and guide were manufactured using an internal printed and inspected.The parts were able to pass relevant manufacturing inspection checks (ff-psg-507) to stability and trajectory.No evidence of nonconformance identified.Loss of motors may be due to a variety of different reasons.Based on this, a root cause for the loss of motors cannot be definitively concluded.Based on information received from the customer, the surgeon did not believe he had seated the guide appropriately and medially breached.Without radiographs, a medial breach cannot be confirmed.All evidence indicated that the guide provided to the customer was conforming.It cannot be confirmed or refuted that the guide caused or contributed to the patient injury.
Event or Problem Description
Event description as evaluated: during an initial posterior spinal fusion surgery utilizing firefly guides, a patient lost motors during the procedure.The procedure was stopped after loss of motors and all hardware was removed.The patient recovered motors after the procedure.The procedure was continued and completed approximately four months later with no issues and a successful outcome.

• Brand Name: FIREFLY
• Common Device Name: PATIENT-SPECIFIC PEDICLE SCREW GUIDE
• Manufacturer (Section D): MIGHTY OAK MEDICAL; 750 w. hampden ave; suite 120; englewood CO 80110
• MDR Report Key: 11508611
• Report Number: 3011818499-2021-00001
• Device Sequence Number: 19790198
• Product Code: PQC
• UDI-Device Identifier: 00851662007001
• UDI-Public: 00851662007001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: FF-101-XX
• Device Catalogue Number: FF-PSG-0001
• Device Lot Number: 20ADAN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 13 YR