FIREBIRD NXG 36-2101Recalls & reported problems

Orthofix US LLC · TOP LOADING BODY · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18257200110254), received between Feb 3, 2025 and Feb 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth2

Patient problems

Failure of Implant2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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. UPON FURTHER DISCUSSION WITH THE DISTRIBUTOR, IT WAS REPORTED THAT THE 36-2101 TOP LOADING BODY WAS NOT EXPLANTED FROM THE PATIENT, NOR INVOLVED IN A MALFUNCTION OR ADVERSE EVENT. THIS FOLLOW UP REPORT IS TO CANCEL THIS SUBMISSION. PLEASE REFERENCE MFR REPORT NUMBER 2183449-2025-00005 FOR THE SUBJECT DEVICE AND REPORT.
Patient problems: Failure of Implant
MAUDE report 21327028 ↗
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. UPON FURTHER DISCUSSION WITH THE DISTRIBUTOR, IT WAS REPORTED THAT THE 36-2101 TOP LOADING BODY WAS NOT EXPLANTED FROM THE PATIENT, NOR INVOLVED IN A MALFUNCTION OR ADVERSE EVENT. THIS FOLLOW UP REPORT IS TO CANCEL THIS SUBMISSION. PLEASE REFERENCE MFR REPORT NUMBER 2183449-2025-00001 FOR THE SUBJECT DEVICE AND REPORT.
Patient problems: Failure of Implant
MAUDE report 21293365 ↗

Device details

UDI-DI	`18257200110254`
Brand	FIREBIRD NXG
Model	36-2101
Company	Orthofix US LLC
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	K180179
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 20, 2026

Device type (GMDN): Bone-screw internal spinal fixation system, non-sterile

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Other Thoracolumbosacral pedicle screw system devices

EXPEDIUM VERSE 199721000
Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
387 reports
Sequoia® 3301-1
Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
184 reports
CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
179 reports
Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Thoracolumbosacral pedicle screw system devices →

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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