Modulus 1181845P2Recalls & reported problems
Nuvasive, Inc. · Modulus XL, 8x18x45mm 10° · 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 00887517726025), received between Feb 22, 2023 and Feb 22, 2023 — 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.
Most reported problems
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2023Migration; Migration
ON (B)(6) 2023, A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM L3 TO L5 WHERE SPACER IMPLANT WERE PLACED BETWEEN EACH LEVEL. THE SURGERY WAS COMPLETED WITH NO ISSUE WITH THE A SECONDARY SURGERY TO COMPLETE THE PROCEDURE BEING SCHEDULED ON (B)(6) 2023. ON (B)(6) 2023, IT WAS DISCOVERED THE IMPLANT INSTALLED AT THE L3-L4 LEVEL HAD MIGRATED ROUGHLY 7MM TO THE LEFT. THE SECONDARY PORTION OF THE PROCEDURE WAS COMPLETED ON (B)(6) 2023 WHERE FIXATION WAS IMPLANTED. DURING THIS PROCEDURE THE MIGRATED IMPLANT WAS LEFT AS IS. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AS A CONSEQUENCE OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16421139 ↗
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- 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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