Regatta Lateral System 36-230855-10Recalls & reported problems
Seaspine Orthopedics Corporation · Lateral Implant, 23mm x 8mm x 55mm, 10 Deg · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981162146), received between Apr 11, 2019 and Apr 11, 2019 — classified as 1 malfunction.
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
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2019Migration; Migration
ON (B)(6) 2019, THE PATIENT UNDERWENT A ONE-LEVEL LATERAL LUMBAR INTERBODY FUSION (LLIF) USING THE REGATTA LATERAL SYSTEM SUPPLEMENTED WITH UNILATERAL SCREWS. DURING A ROUTINE PATIENT FOLLOW-UP, X-RAYS WERE TAKEN, AND IT WAS OBSERVED THAT THE IMPLANT HAD MIGRATED OUT OF THE DISC SPACE. AT THE TIME OF LAST CONTACT, PATIENT WAS ASYMPTOMATIC, AND THE SURGEON DID NOT PLAN TO REVISE BUT WOULD CONTINUE TO MONITOR. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8505573 ↗
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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