Xpress Minimally Invasive Pedicle Screw System T073-1000Recalls & reported problems
Xtant Medical Holdings, Inc. · ROTATING ROD INSERTER 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 M697T07310001), received between Mar 27, 2019 and Apr 1, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2019Break; Break
THE COMPLAINANT REPORTED THAT WHILE INSERTING A ROD, THE DISTAL TIP OF AN INSERTER BROKE. THE SURGEON WAS ABLE TO SUCCESSFULLY FINISH THE SURGERY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471542 ↗MalfunctionMar 27, 2019Break; Break
THE COMPLAINANT REQUESTED TO RETURN A SERIOUS OF BROKEN INSTRUMENTS FOR REPLACEMENT. THE COMPLAINANT WAS UNABLE TO PROVIDE DETAILS REGARDING THE INCIDENTS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE MALFUNCTIONS. THE FOLLOWING MDRS ARE RELATED TO THE RECEIPT OF THIS COMPLAINT. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8457353 ↗
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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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