RISE 193.101Recalls & reported problems
Globus Medical, Inc. · RISE Spacer 10x22mm, 7-13mm · Class 2 · Implant
All models of RISE (14)
Data updated Oct 16, 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 00889095213508), received between Mar 1, 2024 and Mar 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Adverse Event Without Identified Device or Use Problem1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A RISE SPACER WHICH HAD COLLAPSED.
Patient problems: Failure of Implant
MAUDE report 18825270 ↗MalfunctionMar 1, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A REVISION WAS DONE TO REPLACE A RISE SPACER AT L5 WHICH HAD MIGRATED POST-OPERATIVELY. THE LOCKING CAP AND ROD WERE ALSO REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 18817010 ↗
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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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