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

Model Number	411000
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on visual inspection and analysis of the returned components, it was determined that the explants are from different generations of the mariner pedicle screw system.The screw tulips returned are mariner gen 2 with the rhomboid thread, and the set screws are mariner gen 1 with the square thread.These implants are not intended to be paired together and likely contributed to the failure reported.There was no significant damage or issues noted while inspecting the returned components other than the mismatched generations.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 consisting of seaspine's mariner pedicle screw system on (b)(6) 2021.It was reported that the patient heard pops and felt pain postoperatively.During a 4-week follow up appointment, it was discovered that 2 set screws separated from the construct.The surgeon and patient elected to proceed with a revision surgery, which took place on (b)(6) 2021 and consisted of explanting the seaspine hardware and replacing with another manufacturer's.The seaspine explants were returned to seaspine for analysis on (b)(6) 2021.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SET SCREW
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11780920
• Report Number: 3012120772-2021-00038
• Device Sequence Number: 17028093
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 05/05/2021

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: 411000
• Device Catalogue Number: 411000
• Device Lot Number: AW78876B/AW85285B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention