MLX 2103828Recalls & reported problems
Nuvasive, Inc. · MLX, 10x38x28mm 12° · 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 00887517263858), received between Jan 12, 2016 and Jan 12, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2016Migration or Expulsion of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Migration or Expulsion of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated
ON (B)(6) 2015 A (B)(6) MALE WAS IMPLANTED WITH AN EXPANDABLE LUMBAR INTERBODY DEVICE AT L4-L5 AND L5-S1. THE PATIENT COMPLAINED OF PAIN AFTER SUSTAINING A FALL. RADIOGRAPHS REVEALED THE DEVICE HAD MIGRATED. THE PATIENT WAS REVISED ON (B)(6) 2015 AND THE DEVICE WAS REPLACED WITH AN ALTERNATE INTERBODY SPACER.
Patient problems: Failure of Implant; Pain
MAUDE report 5362499 ↗
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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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