MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION REGATTA LATERAL SYSTEM; REGATTA LATERAL INSERTER

Model Number	36-90-3000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated by quality compliance and product development.Visual inspection confirmed that the distal tip of the inserter's inner shaft had sheared off.While the exact root cause could not be determined, the failure may be attributed to factors such as patient anatomy, deviation from the recommended surgical technique, or overtightening/excessive torque during implant insertion.Review of labeling: possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: bending, disassembly, or fracture of implant and components.Pain, discomfort, or abnormal sensations due to the presence of the device serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrhythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, including hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism; or death.
Event or Problem Description
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.

• Brand Name: REGATTA LATERAL SYSTEM
• Common Device Name: REGATTA LATERAL INSERTER
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 22188716
• Report Number: 3012120772-2025-00039
• Device Sequence Number: 18231865
• Product Code: MAX
• UDI-Device Identifier: 10889981162306
• UDI-Public: 10889981162306
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K181079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 36-90-3000
• Device Catalogue Number: 36-90-3000
• Device Lot Number: CR55574E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 56700100 OSTEOSTRAND FIBERS, LARGE.; WL4-105010 LATERAL IMPLANT, 18MM X 10MM X 50MM, 10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female