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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, Classified
    XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.

Other ORTHOSIS, SPINAL PEDICLE FIXATION devices

All ORTHOSIS, SPINAL PEDICLE FIXATION devices →

Sources and updates

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