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

Model Number 41-1010

Device Problem Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

A revision surgery was performed to reinstrument the construct; however, the suspect/explanted device has not been returned to seaspine for analysis.Review of the x-ray provided confirms the s1 set screw loosened from the construct in the postoperative period.The cause of this event cannot be determined at this time as no additional information surrounding the surgical technique and/or events leading up to the failure were provided.Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components.

Event Description

A patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system from levels l4-s1; index surgery date unknown.It was reported that a set screw loosened from the construct 3 weeks post-operation.

• 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: taara maharaj ; 5770 armada drive; carlsbad, CA 92008 ; 9517042800
• MDR Report Key: 11943787
• MDR Text Key: 264997809
• Report Number: 3012120772-2021-00052
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• 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
• Patient Outcome(s): Other; Required Intervention