FIREFLY® FF-101-XXRecalls & reported problems
Mighty Oak Medical, Inc. · Patient-Specific Pedicle Screw Guide · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851662007001), received between Apr 5, 2019 and Mar 17, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- Discomfort1
- Nervous System Injury1
- Unspecified Nervous System Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
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.
Patient problems: Nervous System Injury; Unspecified Nervous System Problem
MAUDE report 11508611 ↗InjuryApr 5, 2019Use of Device Problem; Use of Device Problem
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.
Patient problems: Discomfort
MAUDE report 8488010 ↗
Other Orthosis, Spinal Pedicle Fixation devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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