Calibrate 261-PRO-08225515-SRecalls & reported problems
Alphatec Spine, Inc. · LTX NANOTEC SPACER, 8 x 22 x 55 mm, 15° · 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 00190376596037), received between Apr 13, 2026 and Apr 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Migration
IT WAS REPORTED THAT A PATIENT FELL 5 DAYS POSTOPERATIVELY, CAUSING THE EXPANDABLE INTERBODY SPACER TO MIGRATE. REVISION SURGERY OCCURRED ON (B)(6) 2026 TO REMOVE AND REPLACE THE SPACER.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 24864188 ↗
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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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