Coalesce 4090288P2Recalls & reported problems
Nuvasive, Inc. · COALESCE Straight, 9x10x28mm 8° · Class 2 · Implant
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 00887517056399), received between Oct 19, 2024 and Oct 19, 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
- 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.
MalfunctionOct 19, 2024Migration; Migration
THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE PMCF INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L4/5. ON (B)(6) 2024, X-RAYS DEMONSTRATE THAT THE INTERBODY HAS MIGRATED FROM THE DISC SPACE BACK INTO THE RIGHT FORAMEN. ON (B)(6) 2024, A L4-5 TLIF REVISION TOOK PLACE WITH NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20489135 ↗
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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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