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

Catalog Number	41-1000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned.No product information was given, and no further evaluation of the product can be completed at this time.Radiograph received confirms the malfunction of the set screw (inferior end) on the left side.It is unknown if the patient followed post-operative instructions or sustained a fall that may have contributed to the implant's 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 or Problem Description
Initial spinal surgery was performed on l3 - s1 on (b)(6) 2018.During a follow up, it was discovered the inferior left set screw and rod dislodged from the tulip.Revision surgery was competed on (b)(6) 2018 to re-fixate the lock screw and position rod into tulip.Patient was asymptomatic.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 7580924
• Report Number: 3012120772-2018-00011
• Device Sequence Number: 13968913
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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: Physician
• Device Catalogue Number: 41-1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR