Fortex Pedicle Screw System X070-0011Recalls & reported problems

Xtant Medical Holdings, Inc. · Cross Bar Connector Assembly, 45-60mm · Class 2 · Implant

All models of Fortex Pedicle Screw System (14)

Data updated Oct 18, 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 M697X07000111), received between Dec 20, 2019 and Dec 20, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K090224, K120832, K152132); they may or may not involve this specific model.

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

Patient Device Interaction Problem2

Patient problems

Pain2

Recent adverse event reports

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

InjuryDec 20, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
A COMPLAINANT COMMUNICATED ON 11/22/2019 THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 DUE TO NON-FUSION AND POTENTIAL LOOSENING HARDWARE. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 3005031160-2019-00052, 3005031160-2019-00053, 3005031160-2019-00054, 3005031160-2019-00055, 3005031160-2019-00056, 3005031160-2019-00057, 3005031160-2019-00058, 3005031160-2019-00059, 3005031160-2019-00060, 3005031160-2019-00061, 3005031160-2019-00062.
Patient problems: Pain
MAUDE report 9508000 ↗
InjuryDec 20, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
A COMPLAINANT COMMUNICATED ON 11/22/2019 THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 DUE TO NON-FUSION AND POTENTIAL LOOSENING HARDWARE. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 3005031160-2019-00052, 3005031160-2019-00053, 3005031160-2019-00054, 3005031160-2019-00055, 3005031160-2019-00056, 3005031160-2019-00057, 3005031160-2019-00058, 3005031160-2019-00059, 3005031160-2019-00060, 3005031160-2019-00061, 3005031160-2019-00063.
Patient problems: Pain
MAUDE report 9507995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090224, K120832, K152132. One submission often covers many models, so check the product and lot details in each record.

Z-1773-2026 · Feb 18, 2026 · Open, Classified
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Z-1884-2017 · Apr 12, 2017 · Terminated
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Stra
Z-1823-2015 · Apr 7, 2015 · Terminated
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Z-1512-2015 · Mar 11, 2015 · Terminated
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar con

Device details

UDI-DI	`M697X07000111`
Brand	Fortex Pedicle Screw System
Model	X070-0011
Company	Xtant Medical Holdings, Inc.
Product code	MNH · Orthosis, spondylolisthesis spinal fixation
Class	Class 2
FDA submission	K090224, K120832, K152132
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 20, 2024

Device type (GMDN): Bone-screw internal spinal fixation system connector

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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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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