Regatta Lateral System 36-231055-15Recalls & reported problems
Seaspine Orthopedics Corporation · Lateral Implant, 23mm x 10mm x 55mm, 15 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 10889981162153), 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
- Off-Label Use1
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, 2019Off-Label Use; Migration; Off-Label Use; Migration
ON (B)(6) 2019, THE PATIENT UNDERWENT A THREE-LEVEL LATERAL LUMBAR INTERBODY FUSION (LLIF) USING THE REGATTA LATERAL SYSTEM. DURING A ROUTINE PATIENT FOLLOW-UP, X-RAYS WERE TAKEN, AND IT WAS OBSERVED THAT THE IMPLANT HAD MIGRATED LATERALLY BUT STAYED CONTAINED WITHIN THE DISC SPACE AND AN OSTEOPHYTE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT REMOVED THEIR BRACE PRIOR TO WHEN INSTRUCTED. ADDITIONALLY, FIXATION WAS NOT USED TO SUPPLEMENT THE INTERBODY PLACEMENT AND IS CONSIDERED OFF-LABEL USE. AT THE TIME OF CONTACT, IT WAS UNKNOWN IF THE SURGEON WILL REVISE AND PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8504039 ↗
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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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