CALIBER 594.226Recalls & reported problems
Globus Medical, Inc. · CALIBER Spacer 12 x 26mm, 10-15mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849044020809), received between Mar 29, 2022 and Jul 7, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Material Protrusion/Extrusion1
- Migration1
Patient problems
- Nerve Damage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2022Material Protrusion/Extrusion; Appropriate Device Problem Term/Code Not Available
PATIENT IS STATUS POST AN L4-5 INTERBODY FUSION FOR SPONDYLOLISTHESIS AND STENOSIS ON DAY ONE. POST OPERATIVE IMAGING ON AFTER TWO DAYS SHOWED GOOD HARDWARE PLACEMENT. 9-DAYS POST OPERATIVE CHECK, WITH NO COMPLAINTS AND GOOD REPORTED RECOVERY. WHO PRESENTED AT 6 WEEK POST OPERATIVE CHECK WITH SEVERE LEFT-SIDED RADICULOPATHY STARTING 2 WEEKS PRIOR AND NOTED TO HAVE A DORSAL EXTRUSION OF THE INTERBODY CAGE AT L4-5 WITH SIGNIFICANT LATERAL RECESS STENOSIS. THE PATIENT REQUIRED REVISION OF THE INTERBODY CAGE AND THE ARTHRODESIS AND REPLACEMENT OF THE CAGE WITH A TITANIUM EXPANDABLE CAGE.
Patient problems: Nerve Damage
MAUDE report 14944193 ↗MalfunctionMar 29, 2022Migration
IT WAS REPORTED THAT A CALIBER SPACER MIGRATED POSTERIORLY SIX MONTHS POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13942406 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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