Modulus 2080252P2Recalls & reported problems
Nuvasive, Inc. · Modulus TLIF-O, 8x10x25mm 12° · 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 00887517878939), received between Jul 17, 2020 and Jul 17, 2020 — 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
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2020, PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS EXPERIENCING RADICULOPATHY PAIN AND ADDITIONAL XRAYS IDENTIFIED THE LEFT SIDED CAGE AT THE L5 TO S1 LEVELS HAD MIGRATED BACK PLACING PRESSURE ON EXISTING NERVE ROOTS. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020, WERE THE CAGES WERE REPOSITIONED MORE MEDIAL AND DEEPER. GRAFTING MATERIAL WAS ALSO PLACED IN THE POSTEROLATERAL GUTTERS. AS PER REPORTER THE PATIENT IS DOING WELL CLINICALLY WITH THE RADICULOPATHY SETTLING.
Patient problems: Pain
MAUDE report 10287453 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- 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
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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