Regatta Lateral System 36-230845-10Recalls & reported problems
Seaspine Orthopedics Corporation · Lateral Implant, 23mm x 8mm x 45mm, 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981162108), received between Jul 10, 2020 and Jul 10, 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
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2020Migration; Migration
ON (B)(6) 2020, THE PATIENT UNDERWENT L3-L5 LATERAL LUMBAR INTERBODY FUSION (LLIF) SURGERY CONSISTING OF THE REGATTA LATERAL SYSTEM. ON 11 JUN 2020, SEASPINE WAS MADE AWARE OF A POSTOPERATIVE IMPLANT MIGRATION AT THE L4/5 LEVEL. A REVISION SURGERY OCCURRED ON (B)(6) 2020 TO REPOSITION THE IMPLANT AND SUPPLEMENT WITH POSTERIOR FIXATION.
Patient problems: Patient Problem/Medical Problem
MAUDE report 10261317 ↗
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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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