X90 Pedicle Screw System N60000329Recalls & reported problems
Xtant Medical Holdings, Inc. · 6.5mm x 50mm Screw Assembly · 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 M697N600003291), received between Jun 12, 2018 and Sep 4, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2018Break; Break
THE COMPANY RECEIVED A PACKAGE OF BROKEN PEDICLE SCREWS AND A BROKEN ROD IN THE MAIL. THERE WERE NO COMPLAINT DETAILS RECEIVED WITH THE PACKAGE. THE COMPANY MADE MULTIPLE ATTEMPTS TO RETRIEVE DETAILS REGARDING THE HARDWARE. THERE WERE NO KNOWN PATIENT COMPLICATIONS.
Patient problems: No Information
MAUDE report 7843684 ↗MalfunctionJun 12, 2018Fracture; Fracture
THE COMPLAINANT REPORTED A PATIENT THAT PRESENTED APPROXIMATELY THREE MONTHS POST OPERATIVE WITH A BROKEN PEDICLE SCREW.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7594416 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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