Modulus 1181850P2Recalls & reported problems
Nuvasive, Inc. · Modulus XL, 8x18x50mm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517726049), received between Jan 12, 2026 and Jan 12, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
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
Patient problems: Unspecified Kidney or Urinary Problem
MAUDE report 24038924 ↗
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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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