Calibrate 420-PRO-08102500-SRecalls & reported problems
Alphatec Spine, Inc. · Calibrate NanoTec PSX, 8 x 10 x 25mm, 20° · Class 2 · Implant
All models of Calibrate (44)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376529813), received between Mar 5, 2025 and May 1, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Collapse” (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.
Reports received per month
Most reported problems
Device problems
- Collapse2
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2025Collapse; Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AND EXPANDED AS INTENDED DURING A SPINAL PROCEDURE PERFORMED ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 3-MONTH POSTOPERATIVE VISIT, THE SURGEON IDENTIFIED A COLLAPSE OF THE CAGE. A REVISION SURGERY WAS PERFORMED TO REMOVE THE COLLAPSED CAGE AND IMPLANT A NEW ONE.
Patient problems: Failure of Implant
MAUDE report 21945193 ↗MalfunctionMar 5, 2025Collapse; Collapse
AT THE 6-MONTH POSTOPERATIVE VISIT, IT WAS OBSERVED THAT THE EXPANDABLE INTERBODY SPACER HAD COLLAPSED. THE PATIENT IS ASYMPTOMATIC. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21531707 ↗
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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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