neoWave LS 23-LCT-2213Recalls & reported problems
Xenix Medical LLC · LUMBAR CAGE, 10W x 22L x 13H, 8 DEG, STRAIGHT · Class 2 · Implant
Data updated Oct 18, 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 00818345024311), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A SURGEON HAD A CASE WHERE THE LUMBAR CAGE IMPLANT HAD SHIFTED POST-OPERATIVELY. THE REP STATED THAT THE PATIENT ORIGINALLY HAD A L4-5 TLIF UTILIZING A 13MM IMPLANT. PATIENT REQUIRED A REVISION SURGERY BECAUSE THE IMPLANT MIGRATED POSTERIORLY THROUGH THE DISC PREP PATHWAY. IN THE REVISION SURGERY, THE SURGEON INCREASED THE HEIGHT OF THE IMPLANT TO A 15MM HEIGHT, WHICH IS EVIDENT IN THE A/P XRAY WHERE THERE IS LESS GAP ABOVE AND BELOW THE IMPLANT AS WAS PREVIOUSLY PRESENT ON THE 13MM. THE PATIENT AGAIN HAD THE 15MM IMPLANT MOVE POSTERIORLY AND REQUIRED A REVISION SURGERY. THE SURGEON REMOVED THE 15MM IMPLANT AND REPLACED IT WITH A ANOTHER MANUFACTURER'S EXPANDABLE TLIF IMPLANT. THIS IS ONE OF TWO RELATED MDRS FOR THIS PATIENT (THIS IS FOR THE FIRST REVISION PROCEDURE).
Patient problems: Pain
MAUDE report 19541352 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
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- 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
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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