MLX 8123828Recalls & reported problems
Nuvasive, Inc. · MLX, 12x38x28mm 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 00887517268945), received between May 18, 2017 and May 18, 2017 — 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
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
INITIAL SURGERY OCCURRED ON (B)(6) 2015 INVOLVING PLACEMENT OF INTERBODY SPACER AND POSTERIOR FIXATION. ON (B)(6) 2017 RECEIVED INFORMATION WHICH INDICATED THE INTERBODY SPACER MIGRATION OF AN MLX IMPLANT. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 6577381 ↗
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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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