Cervalign 725-090Recalls & reported problems
Xtant Medical Holdings, Inc. · CERVALIGN, RIGID SCREW INSERTER · Class 1
Data updated Oct 16, 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 00840311211135), received between May 7, 2025 and Apr 17, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2026. IT WAS REPORTED THAT THE TIP OF A RIGID SCREW INSERTER BROKE WHILE TIGHTENING A SCREW DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. AN ALTERNATIVE INSTRUMENT WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND THERE WAS NO DELAY OR KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS MALFUNCTION. THE BROKEN TIP WAS SUCCESSFULLY RECOVERED FROM THE SCREW HEAD AND DISPOSED OF AT THE HOSPITAL FACILITY. A RETURN AUTHORIZATION WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED BY THE MANUFACTURER FOR ASSESSMENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916670 ↗MalfunctionMay 7, 2025Material Fragmentation; Material Fragmentation
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 04/15/2025. IT WAS REPORTED THAT A RIGID SCREW INSERTER'S TIP BROKE WHILE TIGHTENING A SCREW DURING SURGERY. AN ALTERNATE AVAILABLE INSTRUMENT WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO KNOWN DELAYS IN PROCEDURE OR PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 04/18/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21980887 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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