SABLE 1172.4210SRecalls & reported problems
Globus Medical, Inc. · SABLE Spacer, 12x30, 6-12mm, 8° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095966305), received between Feb 17, 2026 and Feb 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Migration1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Fracture; Migration
IT WAS REPORTED THAT THE SURGEON WAS PLACING A SABLE CAGE AT L3-L4. HE PLACE THE CAGE AND EXPANDED. HE DIDN'T LIKE THE POSITION AND COLLAPSED THE CAGE. WHEN HE COLLAPSED THE CAGE AND REPOSITIONED THE CAGE, THE TIP OF THE SABLE CAGE FELL OFF IN THE DISC SPACE. WE WERE UNABLE TO RETRIEVE THE TIP, IN TRYING TO RETRIEVE THE TIP THE PART WAS PUSHED ANTERIOR. THE SURGEON IS GOING TO MONITOR THIS PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24369766 ↗
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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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