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 Incontinence (1928); Discomfort (2330); Intervertebral Disc Compression or Protrusion (4524)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020 patient developed progressive motor dysfunction, neurogenic bowel and bladder from a large thoracic disc herniation.Patient has chronic pain in the back, numbness in the legs since the surgery and episodic falling.Thoracic stenosis, disc degeneration, and stenosis requiring extension of her previous fusion up to t9 with new development of proximal junctional kyphosis (above the fusion t8-t9), back pain, and persistent urinary dysfunction.The surgeon reviewed the mri at the (b)(6) 2021 visit which failed to reveal any surgical lesions.On (b)(6) 2021 patient was in the emergency room.Mri noted post operative changes with a small disc budge at t5-t6 and t8-t9 focal kyphosis.T9 pedicle screw appears to have migrated and bein the foramen.Since the initial details were received, there has been no further information provded that would contribute to the determination of the root cause.If relevant information is later identified, the record will be reopened and updated.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

On (b)(6) 2020 patient developed progressive motor dysfunction, neurogenic bowel and bladder from a large thoracic disc herniation.Patient has chronic pain in the back, numbness in the legs since the surgery and episodic falling.Thoracic stenosis, disc degeneration, and stenosis requiring extension of her previous fusion up to t9 with new development of proximal junctional kyphosis (above the fusion t8-t9), back pain, and persistent urinary dysfunction.The surgeon reviewed the mri at the (b)(6) 2021 visit which failed to reveal any surgical lesions.On (b)(6) 2021 patient was in the emergency room.Mri noted post operative changes with a small disc budge at t5-t6 and t8-t9 focal kyphosis.T9 pedicle screw appears to have migrated and bein the foramen.

• 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: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15655217
• MDR Text Key: 302245561
• Report Number: 3012120772-2022-00045
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: ALLOGRAFT CHIPS, 60CC; DBM SEASPINE STRAND; MARINER SCREW SYSTEM
• Patient Outcome(s): Other