CALIBER 194.426Recalls & reported problems
Globus Medical, Inc. · CALIBER Spacer 10 x 26mm, 9-13mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849044020298), received between Mar 4, 2024 and Mar 5, 2024 — classified as 1 death, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Insufficient Information1
- Spinal Cord Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED FOR A CALIBER SPACER ENDPLATE THAT BROKE AND MIGRATED 3 DAYS POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18834179 ↗DeathMar 4, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
A REVISION SURGERY WAS PERFORMED TO REMOVE IMPLANTS AT L5-S1 AND EXTEND THE CONSTRUCT TO L4-L5 WITH BILATERAL CALIBER SPACERS AT L4-5. IT WAS DETERMINED THROUGH FINAL INTRAOPERATIVE X-RAY THAT THE CALIBER SPACER IMPLANTED ON THE PATIENT'S RIGHT WAS POSITIONED TOO FAR ANTERIOR. ATTEMPTS WERE MADE TO REMOVE AND PULL BACK THE IMPLANT; HOWEVER, THIS CAUSED THE SPACER TO ADVANCE FURTHER ANTERIORLY. THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS AND WAS FLIPPED SUPINE AND RECEIVED VASCULAR INTERVENTION. THE PATIENT PASSED AWAY.
Patient problems: Spinal Cord Injury
MAUDE report 18826501 ↗
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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 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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