MAUDE Adverse Event Report: SEASPINE, INC. MARINER SET SCREW

Model Number 41-4010

Device Problems Loose or Intermittent Connection (1371); Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Patient underwent revision surgery on (b)(6) 2021, for unspecified reasons at which time it was noted that 1 of 6 lock screws had backed out.The root cause of this event cannot be determined at this time as no implants or x-rays were made available for analysis.The reason for the revision surgery is unknown at this time, and no additional information was provided.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

Patient underwent revision surgery on (b)(6) 2021, for unspecified reasons at which time it was noted that 1 out of 6 lock screws had backed out.The product is not available for return.The reason for the revision surgery is unknown and no additional information was provided.

• Brand Name: MARINER SET SCREW
• Type of Device: SET SCREW
• Manufacturer (Section D): SEASPINE, INC.; 5770 armada drive; carlsbad CA 92069
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada drive; carlsbad, CA 92008 ; 9517042800
• MDR Report Key: 12124751
• MDR Text Key: 265008312
• Report Number: 3012120772-2021-00063
• 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,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41-4010
• Device Catalogue Number: 41-4010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/06/2021
• 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): Other