Calibrate 325-07103005 (UDI 00190376532998)Recalls & reported problems

Alphatec Spine, Inc. · CALIBRATE CCX-O, 7 x 10 x 30mm 5° · Class 2 · Implant

All models of Calibrate (44)

Data updated Oct 18, 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: 3
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376532998), received between Nov 4, 2024 and May 23, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Collapse” (3 reports).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Dec 15, 2024Class IIOpen, 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

Collapse3

Patient problems

Failure of Implant2
No Clinical Signs, Symptoms or Conditions2
Pain1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryMay 23, 2025Collapse; Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE PERFORMED ON (B)(6) 2024. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 6-MONTH POSTOPERATIVE VISIT RADIOGRAPHIC IMAGES IDENTIFIED A COLLAPSE OF THE CAGE. THE PATIENT IS EXPERIENCING SOME PAIN.
Patient problems: Failure of Implant; Pain
MAUDE report 22078350 ↗
MalfunctionDec 30, 2024Collapse; Collapse
AT THE 6-WEEKS POSTOPERATIVE VISIT, RADIOGRAPH IMAGES REVEALED A COLLAPSED EXPANDABLE CAGE. THE PATIENT IS ASYMPTOMATIC. THERE ARE NO PLANS FOR REVISION SURGERY. THE SURGEON WILL CONTINUE TO MONITOR.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21037600 ↗
MalfunctionNov 4, 2024Collapse; Collapse
AT THE 2 MONTH POST-OP VISIT, RADIOGRAPH IMAGES REVEALED A COLLAPSED EXPANDABLE CAGE AT L5/S1. THE PATIENT IS ASYMPTOMATIC. 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 20601360 ↗

Device details

UDI-DI	`00190376532998`
Brand	Calibrate
Model	325-07103005
Company	Alphatec Spine, Inc.
Product code	MAX · Intervertebral fusion device with bone graft, lumbar
Class	Class 2
FDA submission	K232504
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Metallic spinal interbody fusion cage

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Other Intervertebral fusion device with bone graft, lumbar devices

T-PAL 03.812.003
Synthes GmbH · Intervertebral fusion device with bone graft, lumbar
152 reports
T-PAL 03.812.004
Synthes GmbH · Intervertebral fusion device with bone graft, lumbar
120 reports
Catalyft PL Expandable Interbody System 6068073
Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall66 reports
Catalyft PL Expandable Interbody System 6069076
Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall51 reports
Catalyft PL Expandable Interbody System 6068076
Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall46 reports
EIT TLIF Inserter TFT30101
EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar
88 reports
T-PAL 03.812.001
Synthes GmbH · Intervertebral fusion device with bone graft, lumbar
76 reports
Catalyft PL Expandable Interbody System 6069096
Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar
1 recall25 reports

All Intervertebral fusion device with bone graft, lumbar devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page