Cervalign 66-VST-40-16Recalls & reported problems
Xtant Medical Holdings, Inc. · CERVALIGN, VST, 4.0MM, 16MM · Class 2 · Implant
Data updated Oct 13, 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 00810076561530), received between Jun 26, 2025 and Oct 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Material Integrity Problem1
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.
MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2025. IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE PERFORMED ON (B)(6) 2025, THE SURGEON NOTICED METAL SHAVINGS UPON SCREW INSERTION. THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN SURGERY ASSOCIATED WITH THIS COMPLAINT. THE SCREWS WERE UNABLE TO BE RETURNED TO THE MANUFACTURER AS THEY REMAIN IN THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304645 ↗MalfunctionJun 26, 2025Material Integrity Problem; Material Integrity Problem
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 05/30/2025. IT WAS REPORTED THAT A SURGEON NOTICED METAL SHAVINGS AFTER IMPLANTING A SYSTEM PLATE AND SCREWS. THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN SURGERY ASSOCIATED WITH THIS COMPLAINT. THE IMPLANTS WERE UNABLE TO BE RETURNED TO THE MANUFACTURER AS THEY REMAIN IN THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342368 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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