MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER; SET SCREW

Model Number	41-1010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Seaspine was made aware on (b)(6) 2023 that a patient underwent spinal surgery consisting of a seaspine mariner mis system.The index surgery was on (b)(6) 2022.The distributor reported that a construct failure occurred post-operatively.The x-rays provided appear to show that the p/n: 41-1010 set screw loosened at l4.
Additional Manufacturer Narrative
A revision surgery occurred on (b)(6) 2023.Explants were returned for evaluation, but no failures were observed.The amount of translation in combination with the appearance of the implants indicates that the user likely failed to final tighten this side of the construct, allowing the rod to translate postoperatively.

• Brand Name: MARINER
• Common Device Name: SET SCREW
• 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: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 16273161
• Report Number: 3012120772-2023-00001
• Device Sequence Number: 18015533
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Device Lot Number: AW147642D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown