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

Model Number	41-1010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of provided x-ray confirms several set screws have loosened.No surgical intervention is planned at this time.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
Event or Problem Description
A patient underwent spinal surgery utilizing seaspine's mariner pedicle screw system on (b)(6) 2021.Seaspine was made aware on (b)(6) 2022 that set screws had loosened from the construct in the postoperative period.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 14342789
• Report Number: 3012120772-2022-00019
• Device Sequence Number: 5373438
• 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: 2021
• 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): 05/05/2022

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: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (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
• Patient Sex: Male