Modulus 2100308P2Recalls & reported problems
Nuvasive, Inc. · Modulus TLIF-O, 10x10x30mm 8° · 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 00887517880697), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Nerve Damage1
- Numbness1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024Migration; Migration
THIS EVENT WAS IDENTIFIED DURING A REVIEW OF THE PMCF LUMBAR INTERBODY STUDY THAT NOTED A PATIENT UNDERWENT A THORACIC LUMBAR INTERBODY FUSION WITH POSTERIOR FIXATION ON (B)(6) 2023 AT L3/5. ON (B)(6) 2024 AT12 MO. VISIT LUMBAR RADIOGRAPHS REVEALED MILD SUBSIDENCE OF THE L4/5 GRAFT AND A NEUROLOGICAL EXAM REVEALED A LEFT ZONE IV OBTURATOR NERVE DECREASE IN SENSATION. PATIENT IS BEING REVIEWED AND MONITORED.
Patient problems: Nerve Damage; Numbness; Pain
MAUDE report 20092930 ↗
Other Intervertebral fusion device with bone graft, thoracic devices
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- 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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