MAUDE Adverse Event Report: SEASPINE, INC MARINER PEDICLE SCREW SYSTEM; SCREW SET

Model Number 41-1010

Device Problems Loose or Intermittent Connection (1371); Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Patient underwent revision surgery on (b)(6) 2021 for unspecified reasons at which time it was observed that the posterior fixation construct was loosening in 3-level construct from l4-s1, on both sides.The root cause of this event cannot be determined at this time as no implants were made available for analysis.The reason for the revision surgery is unknown currently.It was noted that dr.(b)(6) replaced all previous hardware and fused up to l3 using the mariner system.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

During a revision surgery, dr.(b)(6) observed that the posterior fixation construct was loosening in 3-level construct from l4-s1, on both sides.This occurred 6 months post-operatively.Loosening appears to be at the s1 spine level bilaterally based on ct imaging.The index surgery was performed in (b)(6) of 2020.The case was a previous fusion at l5-s1.Dr.(b)(6) replaced all previous hardware and fused up to l3 using the mariner system.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SCREW SET
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada drive; carlsbad, CA 92008 ; 9517042800
• MDR Report Key: 12146954
• MDR Text Key: 261055737
• Report Number: 3012120772-2021-00064
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/09/2021

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?: Yes
• Device Operator: No Information
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Device Lot Number: 10889981155100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other