Calibrate 320-08102500Recalls & reported problems
Alphatec Spine, Inc. · PSX Lordotic Expandable, 8 x 10 x 25mm, 20° · Class 2 · Implant
All models of Calibrate (44)
Data updated Oct 16, 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 00190376396781), received between Feb 14, 2023 and Jul 25, 2023 — 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 16, 2026.
Most reported problems
Device problems
- Collapse2
Patient problems
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2023Collapse; Collapse
AT THE 2-WEEK POSTOPERATIVE VISIT, A RADIOGRAPH IMAGE REVEALED A UNILATERAL COLLAPSE OF AN EXPANDABLE CAGE. THERE ARE NO PLANS FOR REVISION SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT.
Patient problems: Pain
MAUDE report 17390556 ↗InjuryFeb 14, 2023Collapse; Collapse
IT WAS REPORTED AN INTERBODY CAGE COLLAPSED POSTOPERATIVELY. A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANT.
Patient problems: Insufficient Information
MAUDE report 16375962 ↗
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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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