Calibrate 325-PRO-07103010-SRecalls & reported problems
Alphatec Spine, Inc. · CALIBRATE NanoTec CCX O, 7x10x30mm 10° · Class 2 · Implant
All models of Calibrate (44)
Data updated Oct 18, 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 00190376603995), received between Apr 20, 2026 and Jun 29, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Collapse3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Collapse
POSTOPERATIVE RADIOGRAPHIC IMAGING AT THE 3-MONTH FOLLOW-UP VISIT REVEALED THE EXPANDABLE CAGE HAD COLLAPSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659154 ↗MalfunctionMay 1, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2026. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ABOUT 6 WEEKS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A COLLAPSED CAGE. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059140 ↗MalfunctionApr 20, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON AN UNKNOWN DATE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ABOUT 2 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A COLLAPSE OF THE CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927125 ↗
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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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