TLX 5905936P2Recalls & reported problems
Nuvasive, Inc. · TLX20, 9x11x36mm 15° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517958594), received between Oct 20, 2024 and Oct 20, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE PMCF LUMBAR INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2023 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION AND A POSTERIOR INSTRUMENTED FUSION AT L3/4. ON (B)(6) 2023 THE PATIENT UNDERWENT AN L5-S1 EXTREME LATERAL INTERBODY FUSION AT L4/5 AND L5/S1 WITH POSTERIOR FIXATION EXTENDED L4-S1 FOR AN UNRELATED PRE-EXISTING CONDITION. (CONDITION NOT PROVIDED) ON (B)(6) 2023 PATIENT NOTED AND INFECTION WITH DRAINAGE FROM BACK INCISION. ON (B)(6) 2023 THE PATIENT'S INFECTION REQUIRED AN INCISION AND DRAINAGE. ON (B)(6) 2023 THE PATIENT INFECTION WORSENED REQUIRING A PICC LINE PLACED FOR IV ANTIBIOTICS BUT REPORTED AS RESOLVED ON (B)(6) 2024 AS INFECTIOUS DISEASE NOTES NO SIGN OF INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20490042 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- 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.
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