MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SEASPINE; CORAL

Device Problem Insufficient Information (3190)

Patient Problems Stenosis (2263); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Adjacent segment degeneration is a condition that sometimes occurs after spinal fusion surgery.Whether the degeneration is a result of a previous fusion attempt or the patient's predisposition to continued degeneration is unknown.

Event Description

Chronic persistent left c8 radiculopathy, severe stenosis left c7-t1 neural foramen, 3 mm of spondylolisthesis where symptoms were progressive with motor weakness and intrinsic muscle loss in the left hand.

• Brand Name: SEASPINE
• Type of Device: CORAL
• 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: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13530390
• MDR Text Key: 287261983
• Report Number: 3012120772-2022-00003
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2022
• 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): Required Intervention