MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM; SET SCREW

Model Number 411010

Device Problems Separation Failure (2547); Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The surgeon and patient opted to perform a revision surgery on (b)(6) 2020.The distributor was unable to provide information surrounding the surgical technique, x-rays, or additional information surrounding the revision outcome and/or care plan.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

A patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system on (b)(6) 2020.On (b)(6) 2020, it was reported that the right l4-l5 set screws separated from the tulip, the left l5 bone screw appeared loose, and the left l4 set screw separated from the construct in the postoperative period.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SET SCREW
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11754132
• MDR Text Key: 250243804
• Report Number: 3012120772-2021-00034
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 411010
• Device Catalogue Number: 411010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/30/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention