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

Model Number 41-1010

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The surgeon observed the loosened screws during a post op follow up appointment.The surgeon informed the seaspine representative that the loosened screws did not warrant surgical intervention.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 surgeon informed a seaspine representative that he had observed several set screws coming loose from the constructs in the postoperative period.The surgeon spoke generally and no further information, radiographs, or other details have been provided in relation to the event, despite multiple follow up communications.There are 3 reports for these events: 3012120772-2021-00055 and 3012120772-2021-00056.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SCREW SET
• Manufacturer (Section D): SEASPINE, INC.; 5700 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: 11963006
• MDR Text Key: 264097546
• Report Number: 3012120772-2021-00054
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• 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: 06/08/2021

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: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/08/2021
• 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