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 Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2022 the seaspine clinical team provided an updated sae form for patient (b)(6).The event description in the updated form noted that on (b)(6) 2021 the patient has plateaued in improvement with pain on the left side low back.Also, noted bilateral set nut loosening at l5.Revision to be considered if the patient does not continue to improve.At that time the patient continued physical therapy and the hope was that bracing with the interbody fusion would lead to a solid fusion and reduction in pain.Outcome details: patient reported to be 70% improved as of 10.11.2021 with pain about 4/10.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
On (b)(6) 2022 the seaspine clinical team provided an updated sae form for patient (b)(6).The event description in the updated form noted that on (b)(6) 2021 the patient has plateaued in improvement with pain on the left side low back.Also, noted bilateral set nut loosening at l5.Revision to be considered if the patient does not continue to improve.At that time the patient continued physical therapy and the hope was that bracing with the interbody fusion would lead to a solid fusion and reduction in pain.Note that the initial left l5 set screw loosening was recorded under pr (b)(4).Treatment description: revision posterior spinal fusion l5-s1 with hardware removal and reinsertion with another system.

• 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: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15854374
• Report Number: 3012120772-2022-00052
• Device Sequence Number: 12369460
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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: Not provided
• Initial Report FDA Received Date: 11/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown