TLX 1742606Recalls & reported problems
Nuvasive, Inc. · TLX Implant, 8x11x25mm 15° · 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 00887517670694), received between Oct 12, 2016 and Jan 11, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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. 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 Device2
- Unintended Movement1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2017Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement
A (B)(6) MALE PATIENT UNDERWENT A PROCEDURE AT L4-L5 ON (B)(6) 2016. POST -OP RADIOGRAPHS SHOWED MIGRATION OF THE INTERBODY. A REVISION TOOK PLACE ON (B)(6) 2016 AND THE IMPLANT WAS REPOSITIONED. POST-OP REVISION RADIOGRAPHS CONFIRMED THE DEVICE MIGRATED. ON (B)(6) 2016 THE SECOND REVISION TOOK PLACE, THE DEVICES WERE REMOVED AND REPLACED. NO PATIENT INJURY WAS REPORTED AND ALL EXPLANTS WERE DISCARDED.
Patient problems: Failure of Implant
MAUDE report 6244604 ↗MalfunctionOct 12, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
A (B)(6) MALE PATIENT UNDERWENT A PROCEDURE AT L4-L5 ON (B)(6) 2016. POST-OPERATIVE RADIOGRAPHS SHOWED THE IMPLANT MIGRATED INTO THE FORAMEN. THE PATIENT WAS COMPLAINING OF PAIN. A REVISION TOOK PLACE ON (B)(6) 2016 IN WHICH THE IMPLANT WAS REPOSITIONED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Pain
MAUDE report 6025015 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page