MAUDE Adverse Event Report: SEASPINE, INC NORTHSTAR¿ OCT SPINAL SYSTEM; OCCIPITAL SCREW

Device Problems Mechanical Problem (1384); Separation Problem (4043)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Movement Disorder (4412)

Event Date 06/12/2021

Event Type  malfunction  

Event Description

The customer reported screw loosening bilaterally at c7 and partially at c6.The patient reported worsening balance and later ct showed distal screw loosening bilaterally at c7 and partially at c6.Had revision with regrafting and extension of hardware with removal of lateral screw mass at c7 and revision of pedicle screw fixation c5 to t2 with northstar.Improvement reported on (b)(6) 2021; however, pain persists with another fall in (b)(6) 2022.One week prior to the (b)(6) 2021 visit, the patient reported worsening of balance and coordination and was put on a medrol dose pack.Mri taken at (b)(6) 2021 showed a widely patent spinal canal without any cord compression and normal cord signal with no progression of myelopathy.Ct was ordered and completed in 08.2021 and showed distal screw loosening bilaterally at c7 and partially at c6 while c5 looked solid.Fusion bone graft was still nonconfluent.

Manufacturer Narrative

One week prior to the (b)(6) 2021 visit, the patient reported worsening of balance and coordination and was put on a medrol dose pack.Mri taken at (b)(6) 2021 showed a widely patent spinal canal without any cord compression and normal cord signal with no progression of myelopathy.Ct was ordered and completed in (b)(6) 2021 and showed distal screw loosening bilaterally at c7 and partially at c6 while c5 looked solid.Fusion bone graft was still nonconfluent 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: NORTHSTAR¿ OCT SPINAL SYSTEM
• Type of Device: OCCIPITAL 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: taara maharaj ; 5770 armada drive; carlsbad, CA 92008 ; 9517042800
• MDR Report Key: 14458602
• MDR Text Key: 300335670
• Report Number: 3012120772-2022-00022
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• 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): Other; Required Intervention