FIREBIRD NXG 36-2001Recalls & reported problems
Orthofix US LLC · SET SCREW · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 18257200084487), received between Oct 14, 2020 and Mar 11, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information4
- Failure of Implant3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 36-2001 SET SCREW BACKED OUT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24575009 ↗MalfunctionMar 11, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 36-2001 SET SCREW BACKED OUT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24569223 ↗MalfunctionMar 11, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 36-2001 SET SCREW BACKED OUT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24569222 ↗MalfunctionFeb 6, 2025Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT WENT TO A FOLLOW UP VISIT 3-4 WEEKS AFTER SURGERY AND A SET SCREW WAS FOUND TO BE LOOSE ON POST OP IMAGING AT L2-L3 LEVEL. THE PATIENT REQUIRED A REVISION SURGERY THAT EXTENDED UP ONE LEVEL FROM PREVIOUS HARDWARE. PATIENT DID NOT REPORT ANY PAIN. FURTHER DETAILS WERE REQUESTED. NO FURTHER DETAILS HAVE BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 21327513 ↗MalfunctionFeb 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT WENT TO A ROUTINE FOLLOW UP VISIT AFTER A DECOMPRESSION AND FUSION WITH THE USE OF FENESTERATED SCREWS THAT WERE IMPLANTED (B)(6) 2024. THE FOLLOW UP EXAM CONSISTED OF IMAGING THAT SHOWED SET SCREW BACKED OUT ON AN L2 -PELVIS JANUSUS FENESTRATED CASE. THE PATIENT REQUIRED A REVISION SURGERY THAT TOOK PLACE ON (B)(6)2025. NO SYMPTOMS WERE REPORTED BY PATIENT.
Patient problems: Failure of Implant
MAUDE report 21326995 ↗MalfunctionFeb 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT WENT TO A ROUTINE FOLLOW UP VISIT AFTER A DECOMPRESSION AND FUSION WITH THE USE OF FENESTERATED SCREWS THAT WERE IMPLANTED (B)(6)2024. THE FOLLOW UP EXAM CONSISTED OF IMAGING THAT SHOWED SET SCREW BACKED OUT ON AN L2 -PELVIS JANUSUS FENESTRATED CASE. THE PATIENT REQUIRED A REVISION SURGERY THAT TOOK PLACE ON (B)(6)2025. NO SYMPTOMS WERE REPORTED BY PATIENT.
Patient problems: Failure of Implant
MAUDE report 21293671 ↗MalfunctionOct 14, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
INFORMATION PROVIDED STATES THAT PATIENT HAD L3-S1 POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY ON (B)(6) 2020. IN WAS FOUND VIA X-RAYS DURING FOLLOW-UP VISIT THAT TWO OF THE LOCKING CAPS FROM S1 HAD BECOME LOOSE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO REMOVE AND REPLACE THE HARDWARE AT S1.
Patient problems: Insufficient Information
MAUDE report 10680951 ↗
Other Thoracolumbosacral pedicle screw system devices
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- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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