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

Model Number	FF-101-XX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of dhr did not find any deviations or abnormalities.Review of complaint history did not identify any additional complaints on this item for breaches resulting in revision.Review of returned product determined that the returned product was within specifications.The final root cause determination was identified to be user error in placement of the guide.This root cause was concluded based on discussions with the surgeon using the guide, bone model and post-op ct scan.No further actions are required.
Event or Problem Description
It was reported that during the patients initial posterior spinal fusion operation using firefly patient-specific pedicle screw guide, while using the l4 guide on the l4 level in the patient, the left screw was placed laterally and the right screw was placed medially.Furthermore, the patient presented with pain and radiculopathy two weeks post-op and required a revision procedure to reposition these screws.

• 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: 8488010
• Report Number: 3011818499-2019-00001
• Device Sequence Number: 2515740
• Product Code: PQC
• UDI-Device Identifier: 00851662007001
• UDI-Public: 00851662007001
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K181399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 06/14/2019
• Device Model Number: FF-101-XX
• Device Catalogue Number: FF-PSG-0001
• Device Lot Number: 18PAHK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Distributor Facility Aware Date: 03/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/05/2019
• 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: Required Intervention
• Patient Age: 13 YR