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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/14/2021

Event Type  Injury  

Event Description

A patient underwent spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system, medtronic's magnifuse, and seaspine's strand from level l4-pelvis.Seaspine became aware on 2022 sep 27 that the patient was experiencing some hardware irritation related to the iliac bolts (level s1-pelvis) and a removal occurred on (b)(6) 2021.The lock nut and connector was removed and the iliac bolt was removed bilaterally.Both rods were shortened down just below the s1 screws.

Manufacturer Narrative

It was reported that as of (b)(6) 2021 the patient stated she is 100% better and happy with her progress.She is not having much leg or back pain and denies having numbness or weakness.Patient to resume some activities slowly (i.E.Running).This complaint was submitted by the stronger together clinical study registry.There were no product lot numbers provided to perform trending or device history record review.Should any product be returned or if any additional information or substantive discoveries are made, the complaint will be reevaluated.Per the serious adverse event form completed by the clinical site/surgeon, this was not a product malfunction and the failure was not related to the seaspine study product.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE 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
• MDR Report Key: 15631294
• MDR Text Key: 301983865
• Report Number: 3012120772-2022-00046
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• 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
• Treatment: MEDTRONIC MAGNIFUSE; SEASPINE STRAND
• Patient Outcome(s): Other
• Patient Sex: Female