MAUDE Adverse Event Report: SEASPINE INC. MARINER PEDICLE SCREW SYSTEM; SCREW/SHANK

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Erosion (1750)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

The mariner screw shanks were not returned for investigation as they remain in the patient.No additional medical treatment has been reported; the patient will continue to be monitored for any indications prompting additional treatment or intervention.No radiographs, part, or lot information were provided for analysis.

Event Description

Patient (b)(6) underwent spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system from levels t1-t11.At the patient's 12-month follow up on (b)(6) 2020, proximal junctional kyphosis without fracture or gross hardware failure was noted.Additionally, the top screws at level t1-t2 were reported to be eroded slightly into the proximal disc space.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SCREW/SHANK
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 11351090
• MDR Text Key: 250246085
• Report Number: 3012120772-2021-00016
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2021
• 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