Modulus 1225260P2Recalls & reported problems
Nuvasive, Inc. · Modulus XLW, 12x22x60mm 15° · Class 2 · Implant
All models of Modulus (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517726964), received between Jun 17, 2019 and Jun 17, 2019 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WHERE A MODULUS CAGE WAS PLACED. ON AN UNKNOWN DATE, POSTOPERATIVE RADIOGRAPHS NOTED THAT THE CAGED HAD MIGRATED ANTERIORLY. A REVISION PROCEDURE IS BEING PLANNED BUT HAS NOT BEEN CONFIRMED. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8705949 ↗
Other Intervertebral fusion device with bone graft, thoracic devices
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- Modulus 1225255P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- CoRoent 6130923P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- Cohere 6120308P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- Modulus 1181050P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- Modulus 1181055P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- TLX 5902826P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic1 report
- CoRoent 5281348P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic1 report
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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