RISE 193.122Recalls & reported problems
Globus Medical, Inc. · RISE Spacer 10x26mm, 8-15mm, 10° · Class 2 · Implant
All models of RISE (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095213577), received between Jan 15, 2021 and Mar 5, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Separation1
- Migration1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Migration; Migration
IT WAS REPORTED THAT THE RISE SPACER EXPERIENCED A SLIGHT COLLAPSE POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18838909 ↗InjuryMar 2, 2024Material Separation; Material Separation
IT WAS REPORTED BY GLOBUS MEDICAL JAPAN, THAT A RISE SPACER BACKED OUT APPROXIMATELY 4 MONTHS POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18823404 ↗MalfunctionJan 11, 2023Break
IT WAS REPORTED THAT AN ASSEMBLED RISE IMPLANT BROKE APART WHILE BEING REPOSITIONED, AND PARTS OF THE IMPLANT WERE LEFT IN THE PATIENT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Foreign Body In Patient
MAUDE report 16139600 ↗MalfunctionJan 15, 2021Therapeutic or Diagnostic Output Failure
IT WAS REPORTED BY A REPRESENTATIVE FROM THE (B)(6) THAT A REVISION SURGERY WAS DONE TO REMOVE A RISE CAGE AND REPLACE IT WITH A SMALLER FOOTPRINT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11181190 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 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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