Modulus 1181245P2Recalls & reported problems
Nuvasive, Inc. · Modulus XL, 12x18x45mm 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 00887517725943), received between Nov 11, 2021 and Nov 11, 2021 — 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
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2021Migration; Migration
ON (B)(6) 2021 THE FIRST PART OF A TWO PART PROCEDURE WAS PERFORMED. THE FIRST STAGE WAS ANTERIOR COLUMN SUPPORT USING EXTREME ANTERIOR LUMBAR INTERBODY FUSION. AT L4/5 ANOTHER MANUFACTURER'S IMPLANT WAS UTILIZED AND AT L1/4 AND L5/S1 NUVASIVE IMPLANTS WERE USED. POST-OP THE PATIENT REPORTED RIGHT SIDE PAIN. ON (B)(6) 2021 RADIOGRAPHS TAKEN REVEALED THE IMPLANT AT L3/4 MIGRATED. ON (B)(6) 2021 THE SECOND PART OF THE PROCEDURE WAS CONDUCTED WHERE POSTERIOR FIXATION WAS PLACED AND ADDITIONAL RADIOGRAPHS STILL SHOWED THE MIGRATION OF THE IMPLANT AT L3/4. ON (B)(6) 2021 THE PATIENT REPORTED NO PAIN. NO ADDITIONAL REVISION SURGERY IS PLANNED.
Patient problems: Pain
MAUDE report 12797500 ↗
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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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