MAUDE Adverse Event Report: SEASPINE INC. MARINER PEDICLE SCREW SYSTEM; SET SCREW

Model Number 41-1010

Device Problem Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The mariner set screws were not returned for investigation as they remain in-situ.No additional medical treatment has been reported; the patient will continue to be monitored for any indications prompting additional treatment or intervention.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

Patient (b)(4).Underwent spinal surgery on (b)(6)2020 from levels l2-s1 consisting of seaspine's mariner pedicle screw system.It was noted at a postoperative visit on (b)(6) 2020 that the left s1 set screw appeared to have separated from the screw and the right s1 set screw appeared to be loose, but not detached.An x-ray taken on (b)(6) 2021 confirmed separation of the s1 set screws bilaterally with clinical improvement.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SET SCREW
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11268100
• MDR Text Key: 250245875
• Report Number: 3012120772-2021-00014
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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