Xpress Minimally Invasive Pedicle Screw System T073-0700Recalls & reported problems

Xtant Medical Holdings, Inc. · PEDICLE SCREWDRIVER ASSEMBLY · Class 2

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

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M697T07307001), received between Mar 27, 2018 and Mar 27, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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.

Most reported problems

Device problems

Material Fragmentation6
Fracture1

Patient problems

No Known Impact Or Consequence To Patient6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 27, 2019Material Fragmentation; Material Fragmentation
THE COMPLAINANT REQUESTED TO RETURN A SERIOUS OF BROKEN INSTRUMENTS FOR REPLACEMENT. THE COMPLAINANT WAS UNABLE TO PROVIDE DETAILS REGARDING THE INCIDENTS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE MALFUNCTIONS. THE FOLLOWING MDRS ARE RELATED TO THE RECEIPT OF THIS COMPLAINT. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8457355 ↗
MalfunctionMar 27, 2019Material Fragmentation; Material Fragmentation
THE COMPLAINANT REQUESTED TO RETURN A SERIOUS OF BROKEN INSTRUMENTS FOR REPLACEMENT. THE COMPLAINANT WAS UNABLE TO PROVIDE DETAILS REGARDING THE INCIDENTS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE MALFUNCTIONS. THE FOLLOWING MDRS ARE RELATED TO THE RECEIPT OF THIS COMPLAINT. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8457354 ↗
MalfunctionMar 27, 2019Material Fragmentation; Material Fragmentation
THE COMPLAINANT REQUESTED TO RETURN A SERIOUS OF BROKEN INSTRUMENTS FOR REPLACEMENT. THE COMPLAINANT WAS UNABLE TO PROVIDE DETAILS REGARDING THE INCIDENTS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE MALFUNCTIONS. THE FOLLOWING MDRS ARE RELATED TO THE RECEIPT OF THIS COMPLAINT. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8457352 ↗
MalfunctionMar 27, 2019Material Fragmentation; Material Fragmentation
THE COMPLAINANT REQUESTED TO RETURN A SERIOUS OF BROKEN INSTRUMENTS FOR REPLACEMENT. THE COMPLAINANT WAS UNABLE TO PROVIDE DETAILS REGARDING THE INCIDENTS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE MALFUNCTIONS. THE FOLLOWING MDRS ARE RELATED TO THE RECEIPT OF THIS COMPLAINT. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8457351 ↗
MalfunctionMar 27, 2019Material Fragmentation; Material Fragmentation
THE COMPLAINANT REQUESTED TO RETURN A SERIOUS OF BROKEN INSTRUMENTS FOR REPLACEMENT. THE COMPLAINANT WAS UNABLE TO PROVIDE DETAILS REGARDING THE INCIDENTS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE MALFUNCTIONS. THE FOLLOWING MDRS ARE RELATED TO THE RECEIPT OF THIS COMPLAINT. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8457350 ↗
MalfunctionMar 27, 2018Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE COMPLAINANT REQUESTED TO RETURN BROKEN SCREWDRIVER ASSEMBLIES TO THE COMPANY. ADDITIONAL INFORMATION WAS REQUESTED BY THE COMPANY. THE COMPLAINANT RESPONDED STATING THAT THE DAMAGE OCCURED WHEN THE SURGEON WAS LOCKING THE SCREW. THERE WAS NO HARM DONE TO THE PATIENT, AND THERE WERE NO OTHER COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7375305 ↗

Device details

UDI-DI	`M697T07307001`
Brand	Xpress Minimally Invasive Pedicle Screw System
Model	T073-0700
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 25, 2024

Device type (GMDN): Surgical screwdriver, reusable

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Other Orthosis, spinal pedicle fixation devices

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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.

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