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

Model Number	41-1000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs received depicted a diassociated set screw from the straight rod at the s1.No product information or explants have been received.Dhr review and product investigation cannot be completed, as the device remains in-situ.No revision date is planned as the doctor elects to continue to monitor.Factors to consider: generation 1 screw head does not have anti-splay feature.Generation 2 screw head does have anti-splay feature.Surgical technique of locking inferior screws, moving up towards the superior end of construct and reducing the rod in juxtaposition to the screw head could create possible excessive loading at caudal end of construct.Review of labeling notes labeling, warnings and precautions: 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.Postoperative fracture due to trauma, defects or poor bone stock.Postoperative warnings: the patient should be advised that implants may bend, break or loosen despite restriction in activities.The root cause is unknown, but may be the result of some action by the user, which can be the consequence or result or surgical technique.
Event or Problem Description
Follow-up exam radiographs showed the set screw detached at s1.Patient is asymptomatic.Surgeon has elected to monitor patient.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 7920367
• Report Number: 3012120772-2018-00023
• Device Sequence Number: 1936891
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 41-1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR