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

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Patient in for follow-up visit and radiographs demonstrated good fixation except for the t10 junction -mild amount of pulling and haloing.The patient will be evaluated in 12 months for proximal junction failure.Possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: bending, disassembly or fracture of implant and components.

Event Description

Patient in for follow-up visit and radiographs demonstrated good fixation except for the t10 junction -mild amount of pulling and haloing.The patient will be evaluated in 12 months for proximal junction failure.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SCREW
• 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: 14119065
• MDR Text Key: 298798445
• Report Number: 3013130772-2022-00016
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2022
• 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