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	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the x-rays provided confirms levels l2-l5 were fused using seaspine's regatta interbody.It was also confirmed that the set screws in the iliac had separated from the construct.The first part of the revision occurred on (b)(6) 2022, which consisted of removing the seaspine reef to interbody from l5-s1 and replacing it with a seaspine vu apod prime nanometalene interbody to increase stability and decrease some of the load on the pedicle screws (and set screws).The second part of the revision occurred on (b)(6) 2022 to replace the mariner set screws that reportedly loosened for the second time.The mariner lateral connectors were also replaced with closed lateral connectors as additional supplementation to the existing construct.Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components 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 consisting of seaspine's mariner pedicle screw system and seaspine's regatta and reef to intervertebral fusion devices on (b)(6) 2020.On (b)(6) 2022, it was reported that a revision surgery occurred on (b)(6) 2020 to replace three mariner set screws that loosened in the postoperative period (ref: 3012120772-2022-00002 for this event).Two of the three set screws reportedly loosened again, prompting a second revision surgery, which occurred on (b)(6) 2022, prompting this report.

• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13444889
• Report Number: 3012120772-2022-00001
• Device Sequence Number: 4492576
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 02/03/2022

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 02/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEASPINE'S REEF TO INTERBODY; SEASPINE'S REGATTA LATERAL INTERBODY; SEASPINE'S VU APOD PRIME NANOMETALENE INTERBODY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female