MAUDE Adverse Event Report: SEASPINE, INC REGATTA LATERAL INSERTER; LATERAL IMPLANT INSERTER

Model Number	36-90-3000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The regatta lateral inserter was returned and evaluated by product engineers.The tip of the inner shaft had sheared above the threaded portion.The cause of the fracture could not be determined; it is possible that overtightening of the implant onto the inserter could have led to the fracture.The fractured tip remains in the implant.No radiographs were provided.Review of labeling: intraoperative warnings breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
Event or Problem Description
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.

• Brand Name: REGATTA LATERAL INSERTER
• Common Device Name: LATERAL IMPLANT INSERTER
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad 92008
• MDR Report Key: 17218840
• Report Number: 3012120772-2023-00010
• Device Sequence Number: 6185849
• Product Code: MAX
• UDI-Device Identifier: 10889981162306
• UDI-Public: 10889981162306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: CR46749CR2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown