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

Device Problem Use of Device Problem (1670)

Patient Problems Chest Pain (1776); Discomfort (2330)

Event Date 06/05/2021

Event Type  Injury  

Event Description

Patient (b)(6) reported via phone worsening of intercostal chest pain on (b)(6) 2021.The patient has left leg weakness and reoccurring neurological sypents.A ct performed on (b)(6) 2021 revealed left t6 pedicle screw indent into the aorta lateral to the vertebral pedicle.The patient had surgical intervention performed on (b)(6) 2021 to remove t5 &t6 pedicle screws with intervening rod and aortic repair at the t6 level.The event was reported as a sae that was definitively related to the study procedure and study protocol, but not a product malfunction.(vascular impingement by t6 screw).

Manufacturer Narrative

No product malfunction was alleged with the unidentified mariner pedicle screw, however the event is believed to be definitely related to the study product and procedure.The mariner pedicle screw may have contributed to the event by coming into contact with the aorta lateral to the vertebral pedicle due to surgical technique and/or the patients anatomy.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.

• Brand Name: MARINER
• 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: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15610935
• MDR Text Key: 301813964
• Report Number: 3012120772-2022-00044
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• 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: ALLOGRAFT CHIPS; BONE MORPHOGENETIC PROTEING 5CC; DBM MEDTRONIC MAGNIFUSE 30.8CC; DBMSEASPINE STRAND 5CC; SEASPINE VENTURA NANOMETALENE
• Patient Outcome(s): Required Intervention