Calibrate 325-PRO-07103510-SRecalls & reported problems
Alphatec Spine, Inc. · CALIBRATE NanoTec CCX O, 7x10x35mm 10° · Class 2 · Implant
All models of Calibrate (44)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376604039), received between Feb 2, 2026 and Apr 20, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Collapse” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Collapse3
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. BETWEEN 3 WEEKS AND 6 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A COLLAPSE OF THE CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927073 ↗MalfunctionMar 5, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 3-MONTH POSTOPERATIVE VISIT RADIOGRAPHIC IMAGES REVEALED A COLLAPSE OF THE CAGE. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 24523210 ↗MalfunctionFeb 2, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING AN ADJACENT SINGLE LEVEL L5/S1 TLIF PROCEDURE ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 6-WEEK POSTOPERATIVE VISIT A RADIOGRAPHIC IMAGE IDENTIFIED A COLLAPSE OF THE CAGE. THE PATIENT IS ASYMPTOMATIC, AND NO REVISION SURGERY IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 24241881 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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