MAUDE Adverse Event Report: SEASPINE, INC MARINER DEFORMITY; POLYAXIAL HEAD, CLOSED, TITANIUM

Model Number MD-100002

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The report of set screw failure (loosening) was confirmed based on film provided to seaspine.The root cause has not been determined as there have been no devices or instruments returned for evaluation, and there has been no feedback or further information provided.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

The rep reported that a surgeon observed set screw failures post-op.During the index surgery on (b)(6) 2021, mariner hardware was implanted from t11-pelvis with multi-level alif's.At the patient's post op visit, images were taken and showed loosening of the md1-100002 polyaxial head, closed, titanium at the bottom of the construct.It is reported that torques of 105in/lb was used to implant the devices.

• Brand Name: MARINER DEFORMITY
• Type of Device: POLYAXIAL HEAD, CLOSED, TITANIUM
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12753717
• MDR Text Key: 282199372
• Report Number: 3012120772-2021-00080
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K211606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 11/04/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: MD-100002
• Device Catalogue Number: MD-100002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/04/2021
• 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