MLX 4083424Recalls & reported problems
Nuvasive, Inc. · MLX, 8x34x24mm 4° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517264497), received between Jan 12, 2016 and Oct 17, 2020 — classified as 2 malfunctions.
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
- Migration or Expulsion of Device1
Patient problems
- Collapse1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2020Migration; Migration
ON (B)(6) 2020 PATIENT UNDERWENT SPINAL PROCEDURE AT L4/5 LEVELS. AS PER REPORTER, POSTOPERATIVELY, RADIOGRAPHS INDICATED THE IMPLANT HAD MIGRATED. ON (B)(6) 2020 A REVISION PROCEDURE WAS PERFORMED.
Patient problems: Pain
MAUDE report 10694604 ↗MalfunctionJan 12, 2016Migration or Expulsion of Device
(B)(6) FEMALE PATIENT AT L4-S1 HAD A EXPANDABLE LUMBAR INTERBODY SYSTEM WITH BILATERAL PEDICLE SCREWS PLACED ON (B)(6) 2015. TWO MONTHS POST-OPERATIVELY THE DEVICE WAS REPORTED TO HAVE MIGRATED AND POSSIBLY COLLAPSED. THE SURGEON HAS ELECTED TO MONITOR THE PATIENT AS THE IMPLANT IS FUSING IN PLACE. NO REVISION SURGERY IS PLANNED AT THIS TIME. PATIENT IS ASYMPTOMATIC AND DOING WELL.
Patient problems: Collapse
MAUDE report 5362498 ↗
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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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