TLX 1742618Recalls & reported problems
Nuvasive, Inc. · TLX Implant, 10x11x30mm 15° · 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 00887517670816), received between Mar 27, 2017 and Mar 27, 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
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON "(B)(6) 2017" A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A 5-LEVEL PROCEDURE FROM L2-S1. THE PATIENT RETURNED TO THE CLINIC FOR ROUTINE 6-WEEK FOLLOW UP AND IT WAS DISCOVERED VIA RADIOGRAPH THAT THE IMPLANT AT THE L2/3 LEVEL MIGRATED POSTERIORLY. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND NO ACTION OR REVISION IS PLANNED AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6436618 ↗
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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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