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

Model Number 41-1010

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The implant was not made available for review as it remains in-site; however review of the x-ray provided confirms the s1 set screw disassociated from the construct. The patient is asymptomatic and the surgeon will continue to monitor for any indication prompting surgical intervention. Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components 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

A patient underwent spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system from l5-s1. Seaspine was made aware on (b)(6) 2020 of a postoperative set screw disassociation at the s1 level.

• Brand Name: SEASPINE MARINER PEDICLE SCREW SYSTEM
• Type of Device: SET 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: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 10909102
• MDR Text Key: 241813656
• Report Number: 3012120772-2020-00091
• 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

• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial