Calibrate 320-08103000Recalls & reported problems
Alphatec Spine, Inc. · PSX Lordotic Expandable, 8 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376396798), received between Apr 9, 2022 and Apr 19, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Collapse1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2023Collapse; Collapse
IT WAS REPORTED AROUND ONE YEAR POSTOPERATIVE, THE LORDOTIC EXPANDABLE CAGE HAD COLLAPSED. THE PATIENT IS ASYMPTOMATIC. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773220 ↗InjuryOct 12, 2022Migration; Migration
DURING A POSTOPERATIVE VISIT, A RADIOGRAPH INDICATED THE CAGE HAD MIGRATED POSTERIORLY. THE PATIENT REPORTED BACK PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022.
Patient problems: Failure of Implant; Pain
MAUDE report 15591903 ↗MalfunctionApr 9, 2022Break; Break
DURING SURGERY, A PSX LORDOTIC EXPANDABLE, 8 X 10 X 30MM, 20° BROKE WHILE THE SURGEON WAS TRYING TO ACHIEVE MORE LORDOSIS. A BILATERAL CAGE WAS PLACED IN THE DISC SPACE ON THE PATIENT'S RIGHT SIDE IN AN ATTEMPT TO ALLEVIATE THE INITIAL BROKEN CAGE FROM COLLAPSING AND/OR MIGRATING. THIS CAUSED A DELAY IN SURGERY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14068486 ↗
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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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