MAUDE Adverse Event Report: SEASPINE, INC CORAL SPINAL SYSTEM; LOCKING SCREW ASSEMBLY

Device Problem Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the x-ray provided confirmed the locking screws loosened from the construct at the l5 and s1 levels.There was no report of surgical/medical intervention or serious injury.No further information was provided.Review of labeling: possible adverse events.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.

Event Description

Patient (b)(6) underwent spinal surgery consisting of seaspine's coral spinal system on (b)(6) 2017.An independent radiographic reviewer assessed the 12-month post-operative imaging and noted screw loosening at the l5 and s1 levels.Seaspine was made aware of this event on 27 mar 2023 as part of clinical study documentation updates.

• Brand Name: CORAL SPINAL SYSTEM
• Type of Device: LOCKING SCREW ASSEMBLY
• 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 dr.; carlsbad, CA 92008 ; 7607278399
• MDR Report Key: 16761699
• MDR Text Key: 313504170
• Report Number: 3012120772-2023-00007
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2023
• 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): Other