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	Insufficient Information (4580)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The 36-90-3000 regatta lateral inserter was returned and evaluated by product engineers.The inserter tip had sheared off, possibly due to over-tightening of the implant.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.

• 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 ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19361804
• Report Number: 3012120772-2024-00013
• Device Sequence Number: 17093362
• Product Code: MAX
• UDI-Device Identifier: 10889981162306
• UDI-Public: 10889981162306
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/21/2024

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: CR48577CR2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/21/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown