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

Model Number 411000

Device Problems Separation Failure (2547); Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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 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
• Type of Device: 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: 11780920
• MDR Text Key: 249242774
• Report Number: 3012120772-2021-00038
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention