Xpress Minimally Invasive Pedicle Screw System T073-0500-55-DLRecalls & reported problems
Xtant Medical Holdings, Inc. · 5.5 DUAL LEAD, CANNULATED TAP · 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 M697T073050055DL1), received between Jan 7, 2019 and Jan 4, 2023 — 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
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2023Break; Break
THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT A SYSTEM TAP WAS IDENTIFIED AS BROKEN AND REQUESTED TO BE REPLACED. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS NOT RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. FIVE ATTEMPTS TO HAVE THE COMPLAINT INSTRUMENT RETURNED FOR ASSESSMENT AND FINAL DISPOSITION WERE UNSUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 16098537 ↗MalfunctionJan 7, 2019Fracture; Fracture
THE COMPLAINANT REPORTED THAT A TAP BROKE DURING A T10/L4 POSTERIOR FUSION SURGERY ON (B)(6) 2018. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WERE NO KNOWN PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8223794 ↗
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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