neoWave LS 23-LCT-2515Recalls & reported problems
Xenix Medical LLC · LUMBAR CAGE, 10W x 25L x 15H, 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 00818345024441), 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 ANOTHER MANUFACTURER'S EXPANDABLE TLIF IMPLANT. THIS IS ONE OF TWO RELATED MDRS FOR THIS PATIENT (THIS IS FOR THE SECOND REVISION PROCEDURE).
Patient problems: Pain
MAUDE report 19541006 ↗
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 18, 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