CALIBER 194.274Recalls & reported problems
Globus Medical, Inc. · CALIBER Spacer 10 x 30mm, 7mm, 0°-10° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095187076), received between Oct 26, 2021 and Oct 26, 2021 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2021Migration; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT A REVISION WAS COMPLETED DUE TO PATIENT PAIN RELATING TO A CALIBER CAGE. THE CAGE WAS NOT REMOVED AND REMAINS IN THE PATIENT. THIS EVENT OCCURRED IN AUSTRALIA.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 12700445 ↗
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
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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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