Calibrate 420-PRO-07103000-SRecalls & reported problems
Alphatec Spine, Inc. · Calibrate NanoTec PSX, 7 x 10 x 30mm, 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 00190376529721), received between Sep 17, 2025 and Jun 29, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Collapse2
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Unspecified Musculoskeletal problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Collapse
AROUND 11 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGINING REVEALED A COLLAPSED EXPANDABLE CAGE.THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659130 ↗InjurySep 17, 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. A FEW MONTHS POSTOPERATIVELY, THE SURGEON IDENTIFIED THAT THE CAGE HAD COLLAPSED CAUSING THE VERTEBRAL BODY TO ALSO COLLAPSE CAUSING THE PATIENT TO EXPERIENCE PAIN. REVISION SURGERY OCCURRED TO REMOVE THE CAGE.
Patient problems: Failure of Implant; Pain; Unspecified Musculoskeletal problem
MAUDE report 23076463 ↗
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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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