Xpress Minimally Invasive Pedicle Screw System X073-5550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X07355501), received between Feb 6, 2018 and Feb 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2018Fracture; Fracture

  ON (B)(4) 2017, X-SPINE SYSTEMS, INC. RECEIVED EMAIL COMMUNICATIONS REPORTING BROKEN PEDICLE SCREWS. THE EMAIL CONTAINED SIX X-RAYS. THERE WERE NO ADDITIONAL DETAILS IN THE EMAIL COMMUNICATION. X-SPINE MADE THREE ATTEMPTS TO OBTAIN ADDITIONAL COMPLAINT DETAILS. ADDITIONAL DETAILS WERE RECEIVED BY THE COMPLAINANT ON (B)(6) 2018. THE COMPLAINANT STATED THAT "THE DOCTOR SENT THE PATIENT FOR A CONTROL X-RAY AND HE FOUND THAT THE SCREW WAS BROKEN, THE PATIENT NEVER HAD AN INCIDENT THAT MIGHT CAUSE THE BREAKAGE OF THE SCREW." THESE DETAILS CORRESPONDED WITH ONE OF THE X-RAYS. THE REMAINING X-RAYS DEPICT MULTIPLE CASES AND POSSIBLY MULTIPLE PATIENTS, HOWEVER, THE COMPLAINANT ONLY INDICATED THAT IT WAS ONE CASE/ONE PATIENT. X-SPINE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MULTIPLE CASES/PATIENTS. A COMPREHENSIVE REVIEW OF ALL SUPPLIED DATA WAS COMPLETED ON (B)(6) 2018. THE INVESTIGATION INCLUDED A REVIEW OF THE DHF FOR THE SINGLE LOT NUMBER PROVIDED. THE REVIEW WAS UNREMARKABLE AND THERE WERE NO INDICATIONS THAT THE PART WOULD NOT PERFORM AS INTENDED. THE ASSESSMENT OF THE CORRESPONDING X-RAY (#1) SHOWS A BROKEN PEDICLE SCREW SHANK ON THE CAUDAL END OF A 1 LEVEL CONSTRUCT.

  Patient problems: No Code Available

  MAUDE report 7244246 ↗

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.