Fortex Pedicle Screw System X010-0167Recalls & reported problems

Xtant Medical Holdings, Inc. · Rod Fork · Class 2

All models of Fortex Pedicle Screw System (14)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X01001671), received between Nov 20, 2018 and Nov 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Device problems

Material Twisted/Bent1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 20, 2018Material Twisted/Bent; Material Twisted/Bent
THE COMPLAINANT REPORTED DIFFICULTIES REDUCING A ROD INTO A PEDICLE SCREW. THE SURGEON WAS UNABLE TO USE THE PERSUADER OR THE PISTOL GRIP REDUCER. THE SURGEON WAS ABLE TO REDUCE THE ROD USING A ROD FORK. THE ROD FORK WAS DAMAGED WHILE REDUCING THE ROD. THERE WERE NO KNOWN PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8092201 ↗

Device details

UDI-DI	`M697X01001671`
Brand	Fortex Pedicle Screw System
Model	X010-0167
Company	Xtant Medical Holdings, Inc.
Product code	MNI · Orthosis, spinal pedicle fixation
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 20, 2024

Device type (GMDN): Orthopaedic rod reducer

A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Other Orthosis, spinal pedicle fixation devices

NA 04.614.508
Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION
277 reports
CREO 1134.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
112 reports
CREO 1119.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
80 reports
VIPER 186731745
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
43 reports
CD HORIZON® Spinal System 1553201090
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
38 reports
EXPEDIUM 179902000
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
37 reports
CD HORIZON® Spinal System 7540220
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
36 reports
EXPEDIUM VERSE 199721640
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
35 reports

All Orthosis, spinal pedicle fixation 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.

How reports and recalls are matched · Editorial policy · Report an error on this page