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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Perforation (2001)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

The index surgery was on (b)(6) 2020.Seaspine was made aware on 27 sep 2022 that the patient had a pain flare and had an mri on (b)(6) 2021 which noted post-operative changes with pedicle screw fixation at l3-l4 and l4-l5.Ct was ordered and demonstrates lateral perforation of l5 pedicles bilaterally into the psoas muscle.Bridging fusion of l4-l5 in the intertransverse area while there is not convincing evidence of bridging fusion of l3-l4.The left l3 pedicle also screw demonstrates slightly ventral perforation while the right l3 is appropriately positioned.The patient was initially to proceed with surgical intervention following the (b)(6) 2021 however had to cancel.The patient was seen in the urgent care clinic on (b)(6) 2021 with constant aching sharp pain and in clinic on (b)(6) 2021 to proceed with care.Based on ct results showed nonunion at l3-l4.There appears to be confluent fusion at l4-l5, but is not certain.The patient has intractable back pain that is severe in nature.Diagnosis: pseudarthrosis after the fusion, post-laminectomy syndrome at l3-4, l4-5 with mispositioned l5 screws bilaterally.Treatment description: (b)(6) 2021 posterior spinal fusion with posterior lumbar interbody grafting l4-5 and l5-s1.Removal of right l5 screw with extensive decompression and exploration of the right l5 nerve root.The unknown mariner screw was not returned and therefore could not be evaluated.The root cause cannot be determined as the instrument was not provided for evaluation.Additionally, no photos or lot information were received.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

The index surgery was on (b)(6) 2020.Seaspine was made aware on 27 sep 2022 that the patient had a pain flare and had an mri on (b)(6) 2021 which noted post-operative changes with pedicle screw fixation at l3-l4 and l4-l5.Ct was ordered and demonstrates lateral perforation of l5 pedicles bilaterally into the psoas muscle.Bridging fusion of l4-l5 in the intertransverse area while there is not convincing evidence of bridging fusion of l3-l4.The left l3 pedicle also screw demonstrates slightly ventral perforation while the right l3 is appropriately positioned.The patient was initially to proceed with surgical intervention following the (b)(6) 2021 however had to cancel.The patient was seen in the urgent care clinic on (b)(6) 2021 with constant aching sharp pain and in clinic on (b)(6) 2021 to proceed with care.Based on ct results showed nonunion at l3-l4.There appears to be confluent fusion at l4-l5, but is not certain.The patient has intractable back pain that is severe in nature.Diagnosis: pseudarthrosis after the fusion, post-laminectomy syndrome at l3-4, l4-5 with mispositioned l5 screws bilaterally.Treatment description: (b)(6) 2021 posterior spinal fusion with posterior lumbar interbody grafting l4-5 and l5-s1.Removal of right l5 screw with extensive decompression and exploration of the right l5 nerve root.

• Brand Name: MARINER
• Type of Device: MARINER PEDICLE SCREW SYSTEM
• 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: robin quiusky ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 15676900
• MDR Text Key: 302474248
• Report Number: 3012120772-2022-00048
• 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,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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: 09/27/2022
• 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: DBM SEASPINE STRAND.; MARINER SCREW SYSTEM.; SEASPINE VENTURA NM.
• Patient Outcome(s): Other