neoWave LS 23-LCT-2509Recalls & reported problems
Xenix Medical LLC · LUMBAR CAGE, 10W x 25L x 9H, 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 00818345024380), received between Nov 16, 2020 and Nov 16, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration1
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.
InjuryNov 16, 2020Migration; Migration
INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020 FOR PLIF SINGLE LEVEL FUSION AT L5-S1 WITHOUT FINAL POSTERIOR COMPRESSION OF SUPPLEMENTAL FIXATION. POSTERIOR MOVEMENT OF INTERBODY IMPLANTS DISCOVERED ABOUT (6) WEEKS AFTER ORIGINAL SURGERY IMPLANTATION. REVISION SURGERY PERFORMED TO TAMP THE INTERBODY IMPLANTS BACK INTO THE DISC SPACE ANTERIORLY AND THEN COMPRESS ON THE SCREWS TO INCREASE THE LORDOSIS AND INCREASE ENDPLATE CONTACT WITH IMPLANT. SURGICAL REVISION PROCEDURE WAS COMPLETED WITHOUT ISSUE AND PATIENT DISCHARGED IN NORMAL COURSE.
Patient problems: Pain
MAUDE report 10848596 ↗
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
- 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.
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