SABLE 1172.2121SRecalls & reported problems
Globus Medical, Inc. · SABLE Spacer, 10x26, 7-14mm, 15° · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889095966046), received between Mar 5, 2024 and Mar 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A SABLE SPACER HAS BACKED OUT POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18837863 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A SABLE SPACER HAS BACKED OUT POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18837616 ↗
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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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