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

Model 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	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiograph received depicted two disassociated set screws at s1.No product information or explants have not been received.Dhr review and product investigation cannot be completed, as the screws were disposed of by the hospital.Revision surgery removed the set screws, repositioned s1 screw and extended to the ilium.It was reported the patient is overweight and did a fair amount of bending.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 activity.The root cause is unknown, but the patient's fall may have caused or contributed to the event.
Event or Problem Description
Initial surgery was performed from l3 - s1 in (b)(6) 2017 and patient was instrumented with poster fixation.On (b)(6) revision surgery was completed to remove two screws at s1 that had broke mid-shaft.

• Brand Name: MARINER PEDICLE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE; 5770 armada dr.; carlsbad 92008
• MDR Report Key: 7329158
• Report Number: 3012120772-2018-00003
• Device Sequence Number: 11170168
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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 Model Number: 41-1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 40 YR