Regatta Lateral System 36-90-3000Recalls & reported problems
Seaspine Orthopedics Corporation · Regatta Lateral Inserter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889981162306), received between Jun 28, 2023 and Jun 11, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Fracture; Fracture
A PATIENT UNDERWENT LATERAL LUMBAR INTERBODY FUSION (LLIF) ON (B)(6) 2025 UTILIZING THE ORTHOFIX/SEASPINE WAVEFORM L INTERBODY SYSTEM. DURING INSERTION OF THE LATERAL INTERBODY, THE TIP OF THE REGATTA LATERAL INSERTER FRACTURED, AND THE INSTRUMENT FRAGMENT WAS LEFT IN THE IMPLANTED INTERBODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY, AND THERE WERE NO REPORTED PATIENT INJURIES OR NEED FOR ADDITIONAL INTERVENTION.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22188716 ↗MalfunctionMay 21, 2024Fracture; Fracture
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S REGATTA LATERAL SYSTEM. THE 36-90-3000 REGATTA LATERAL INSERTER FRACTURED INTRA-OPERATIVELY AND THE FRAGMENT WAS LEFT INSIDE THE PATIENT. THE CUSTOMER REPORTED THAT THE SURGERY WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 19361804 ↗MalfunctionJun 28, 2023Fracture; Fracture
ON (B)(6) 2023 A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S REGATTA LATERAL SYSTEM. DURING IMPLANT INSERTION, THE REGATTA LATERAL INSERTER TIP FRACTURED AND WAS LEFT IN THE IMPLANT. THE IMPLANT WAS FULLY SEATED AND SECURED WITH BILATERAL PEDICLE SCREWS. NO PATIENT INJURY WAS REPORTED. THERE ARE NO PLANS FOR REVISION OR REMOVAL. NO RADIOGRAPHS WERE PROVIDED. SEASPINE WAS MADE AWARE OF THIS INCIDENT ON 09 JUN 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17218840 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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