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 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

Dr (b)(6) observed a loose set screw at s1.The issue was reported 28 jun 2021.There was no date provided for the event.The construct had been in place since (b)(6) 2021.There were no details provided regarding patient injury or a revision surgery at the time of this report.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 28 jun 2021, it was reported that dr.(b)(6) observed a loose set screw at the s1 segment.The date of the event was not provided.The index surgery was performed (b)(6) 2021.There was no report of patient injury, or details regarding revision.

• 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: 12222206
• MDR Text Key: 263435201
• Report Number: 3012120772-2021-00067
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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
• Date Manufacturer Received: 06/29/2021
• 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