Calibrate 420-PRO-12103000-SRecalls & reported problems
Alphatec Spine, Inc. · Calibrate NanoTec PSX, 12 x 10 x 30mm, 20° · Class 2 · Implant
All models of Calibrate (44)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376529639), received between Jul 21, 2025 and Jul 21, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Collapse” (1 report).
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
- Collapse1
- Migration1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2025Collapse; Migration; Collapse; Migration
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AT LEVEL L5-S1 AND EXPANDED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2024. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 6-WEEK FOLLOW-UP APPOINTMENT, THE SURGEON NOTED THAT THE CAGE WAS MALPOSITIONED, BUT THE PATIENT WAS ASYMPTOMATIC. THE PATIENT CAME IN ABOUT 10 MONTHS POSTOPERATIVELY EXPERIENCING SEVERE RADICULAR SYMPTOMS. RADIOGRAPHIC IMAGES CONFIRMED THAT THE SPACER WAS MALPOSITIONED AND POTENTIALLY COLLAPSED. THE PATIENT DID NOT EXPERIENCE A FALL TO CAUSE THIS. REVISION SURGERY OCCURRED TO REMOVE THE CAGE.
Patient problems: Failure of Implant; Pain
MAUDE report 22559394 ↗
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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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