Xpress Minimally Invasive Pedicle Screw System X073-7540-DLRecalls & reported problems
Xtant Medical Holdings, Inc. · XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 40mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X0737540DL1), received between Jul 25, 2019 and Jul 25, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (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
- Break1
- Fracture1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2019Break; Fracture; Break; Fracture
THE PATIENT INITIALLY UNDERWENT SURGERY ON (B)(6) 2018, FOR AN L2-3 PLIF. THE PATIENT HAD BEEN SEEING A PAIN SPECIALIST AND IT WAS SUSPECTED THAT THE FUSION AT L2-3 WAS INCOMPLETE AND THAT ONE OF THE SCREWS WAS SUSPECTED TO BE LOOSE. THE BROKEN SCREW WAS IDENTIFIED WHEN IT CAME APART AS THE SURGEON WAS ATTEMPTING TO REMOVE IT ON (B)(6) 2019 DURING A REVISION PROCEDURE. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Pain
MAUDE report 8828789 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152132. One submission often covers many models, so check the product and lot details in each record.
- Z-1773-2026 · Feb 18, 2026 · Open, ClassifiedXTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
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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