MLX 4103424Recalls & reported problems
Nuvasive, Inc. · MLX, 10x34x24mm 4° · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517265357), received between Aug 8, 2016 and Apr 2, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device3
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2017 THE PATIENT WAS IMPLANTED WITH AN EXPANDABLE INTERBODY LUMBAR SYSTEM AT L4-L5. SINCE THIS SURGERY THE PATIENT FELL CAUSING THE IMPLANT TO SHIFT POSTERIORLY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 AND THE PATIENT IS DOING WELL. NO PATIENT INJURY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 6452397 ↗MalfunctionMar 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2016 A (B)(6) Y/O WOMAN RECEIVED AN EXPANDABLE INTERBODY WITH BILATERAL POSTERIOR PEDICLE SCREW FIXATION AT S1-L3 WITHOUT ISSUE. ON AN UNKNOWN DATE THE PATIENT SUFFERED A FALL DOWN A FLIGHT OF STAIRS, RADIOGRAPHS VERIFIED THE IMPLANT MIGRATED LATERALLY. A REVISION WAS COMPLETED ON (B)(6) 2017 DURING WHICH THE IMPLANT WAS REPLACED WITHOUT ISSUE.
Patient problems: Failure of Implant
MAUDE report 6390044 ↗MalfunctionAug 8, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
SEVEN MONTHS FOLLOWING IMPLANTATION OF AN INTERBODY SPACER WITH UNILATERAL POSTERIOR FIXATION IN (B)(6) 2015, THE PATIENT REPORTED HAVING RADICULAR SYMPTOMS. REVIEW OF RADIOGRAPHS SUGGESTED THE POSSIBILITY OF IMPLANT MIGRATION. NO INJURY HAS BEEN REPORTED AND NO SURGICAL REVISION OF THE CONSTRUCT HAS OCCURRED AS OF THE REPORT DATE.
Patient problems: Failure of Implant
MAUDE report 5854555 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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