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 Type  malfunction  

Manufacturer Narrative

No implants were made available for review; however review of the x-ray provided confirms the disassociation as reported.The distributor and reporter confirmed the surgeon will be removing the hardware; however, revision surgery information is unknown as the surgeon has elected to use a different manufacturer and did not provide additional information.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

The patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system.The length of the construct and index surgery date are unknown.Seaspine was made aware on (b)(6) 2020 of a set screw disassociation 60 days postop.

• 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: 10905071
• MDR Text Key: 218950952
• Report Number: 3012120772-2020-00087
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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
• Date Manufacturer Received: 10/27/2020
• 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
• Patient Sequence Number: 1