MAUDE Adverse Event Report: SEASPINE INC. MARINER PEDICLE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 41-1000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

(2 of 4): the incident was received through manufacturer's legal department.No product has been returned, no lot number has been provided, no radiographs received and no further evaluation of the product can be completed at this time.The following medwatch numbers are all related to the same incident: 3012120772-2019-00018 ((b)(4)), 3012120772-2019-00020 ((b)(4)), 3012120772-2019-00021 ((b)(4)).It is unknown if the patient followed post-operative instructions or sustained a fall that may have contributed to the implant's alleged disassociation.Review of labeling notes: possible adverse events: delayed union or nonunion (pseudarthrosis), bending, disassembly or fracture of implant and components, 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.Labeling warnings and precautions: based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions.The root cause of this event cannot be determined at this time.No conclusion can be drawn.

Event Description

Index surgery occurred on (b)(6) 2017, which included a partial l4-5 decompressive lumbar laminectomy, left l5-s1 microforaminotomy, l4 to s1 pedicle instrumentation and facet fusion.According to the legal document received, bilateral set screws were broken, and rods were bent.It is unknown how the discovery of broken set screws and bent rods were identified, as no images or medical evaluation were provided.According to the legal document received, the patient sustained injuries which resulted in pain, requiring surgical intervention.Revision occurred on (b)(6)2018, which included removal of manufacturer's fixation system.Current patient condition is unknown.

• Brand Name: MARINER PEDICLE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: aaron ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 8786028
• MDR Text Key: 150878206
• Report Number: 3012120772-2019-00019
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41-1000
• Device Catalogue Number: 41-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• 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; Disability
• Patient Age: 48 YR