Calibrate 325-07103510Recalls & reported problems
Alphatec Spine, Inc. · CALIBRATE CCX-O, 7 x 10 x 35mm 10° · Class 2 · Implant
All models of Calibrate (44)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376533049), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Collapse” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 15, 2024Open, Classified
Complaints have been received regarding post-operative implant collapse.
Z-1065-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Collapse; Collapse
ON (B)(6) 2024, A PATIENT UNDERWENT A LUMBAR INTERVERTEBRAL BODY FUSION PROCEDURE. RADIOGRAPHS TAKEN DURING THE 6-WEEK POSTOPERATIVE VISIT INDICATED A PARTIAL EARLY COLLAPSE OF THE CAGE. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21235528 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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 · each recall links to the FDA recall notice
- 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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