RISERecalls & reported problems across all models
Globus Medical, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 14 models of RISE by Globus Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2017 and Nov 20, 2025 — classified as 4 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Migration” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RISE problems
Device problems
- Migration9
- Collapse2
- Human-Device Interface Problem2
- Mechanical Problem2
- Migration or Expulsion of Device2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant8
- Insufficient Information8
- Foreign Body In Patient2
- Spinal Column Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
RISE models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RISE 193.001Intervertebral fusion device with bone graft, lumbar4 reports
- RISE 193.122Intervertebral fusion device with bone graft, lumbar4 reports
- RISE 193.101Intervertebral fusion device with bone graft, lumbar2 reports
- RISE 193.121Intervertebral fusion device with bone graft, lumbar2 reports
- RISE 193.143Intervertebral fusion device with bone graft, lumbar2 reports
- RISE 193.041Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.102Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.103Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.123Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.151Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.213Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.324Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.332Intervertebral fusion device with bone graft, lumbar1 report
- RISE 193.335Intervertebral fusion device with bone graft, lumbar1 report
Recent RISE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Migration; Migration
IT WAS REPORTED THAT A RISE WAS INSERTED INTO L4/5. AFTER EXPANDING THE RISE, THE SURGEON REVIEWED THE IMAGES AND NOTICED SPACE ANTERIOR INTERVERTEBRAL. THE SURGEON THEN LOWERED THE RISE HEIGHT AND INSERTED IT FURTHER. UPON RE-EXPANDING THE RISE AND REVIEWING THE IMAGES, IT WAS FOUND TO BE OVER-INSERTED. THE SURGEON ATTEMPTED TO CORRECT THE POSITION USING THE INSERTER, BUT THE RISE DISLODGED FROM THE INSERTER. REVIEWING THE IMAGES REVEALED THE RISE HAD DROPPED ANTERIORLY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. THE RISE WAS REMOVED FROM THE PATIENT AT THE HOSPITAL ON (B)(6) 2025.
Patient problems: Foreign Body In Patient
MAUDE report 23605382 ↗InjuryOct 28, 2025Migration; Migration
IT WAS REPORTED THAT RISE IMPLANTS WERE INSERTED AT L3/4/5 BY PLIF ON (B)(6) 2025. AFTER REVIEW OF IMAGE, THE SURGEON DECIDED TO RE-POSITION THE RISE AT RIGHT L4/5. THE SURGEON INSERTED THE INSERTER INTO RIGHT L4/5 TO REPOSITION BUT ACCIDENTALLY PUSHED THE RISE WITH THE INSERTER, CAUSING IT TO FALL VENTRALLY. A NEW RISE WAS INSERTED INTO RIGHT L4/5 AND THE FIXATION PROCEDURE WAS COMPLETED. ON (B)(6) 2025, THE RISE THAT HAD FALLEN INTO THE VENTRAL SPACE WAS REMOVED AT ANOTHER HOSPITAL.
Patient problems: Insufficient Information
MAUDE report 23407579 ↗MalfunctionApr 23, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT DURING INSERTION OF A RISE-L SPACER THE SURGEON NOTICED TRANSUDATE IN THE PATIENT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 21893869 ↗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 ↗MalfunctionMar 5, 2024Migration; Migration
IT WAS REPORTED THAT THE RISE SPACER EXPERIENCED A SLIGHT COLLAPSE POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18838889 ↗MalfunctionMar 5, 2024Migration; Migration
IT WAS REPORTED THAT THE RISE SPACER EXPERIENCED A SLIGHT COLLAPSE POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18838888 ↗MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT PART OF THE SUPERIOR ENDPLATE APPEARS TO BE MISSING OR BROKEN POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18837575 ↗MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO RETRIEVE A RISE SPACER THAT HAD BEEN LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Failure of Implant
MAUDE report 18837332 ↗MalfunctionMar 5, 2024Migration; Migration
IT WAS REPORTED THAT WAS A REVISION TO REPLACE RISE SPACERS THAT HAD MIGRATED POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834232 ↗MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion
IT WAS REPORTED THAT A RISE-L SPACER HAS LOST HEIGHT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18831630 ↗MalfunctionMar 4, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A RISE SPACER COLLAPSED APPROXIMATELY ONE MONTH POST-OPERATIVELY. REVISION SURGERY WAS REQUIRED.
Patient problems: Spinal Column Injury
MAUDE report 18828879 ↗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 ↗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 ↗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 ↗InjuryFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT WAS 8 MONTHS POST-OP FROM ORIGINAL SURGERY AND IT APPEARS ONE OF THE CAGES COLLAPSED. REMOVAL SURGERY OCCURRED (B)(6) 2017.
Patient problems: Failure of Implant
MAUDE report 18809731 ↗
Other Globus Medical, Inc. products
All Globus Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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