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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

During a 9 month post-op examination by surgeon, a follow up ct scan revealed dislodging set screws.The torque setting used for setting the screws was 85in/lb.The surgeon plans to bring in patient for a revision.No other information is available at this time.

Manufacturer Narrative

Clinical circumstances did not warrant removal imminently; however review of film provided confirmed dislodging set screws.The surgeon plans to bring in patient for revision.No other information is available at this time.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.

• Brand Name: MARINER
• 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: joseph bautista ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 12840356
• MDR Text Key: 281864072
• Report Number: 3012120772-2021-00083
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/18/2021
• 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
• Patient Age: 75 YR