MAUDE Adverse Event Report: SEASPINE INC. MARINER PEDICALE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM, PRODUCT CODE: NKB

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	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs received depicted a disassociated set screw at the left s1 pedicle.No product information or explants have not 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.It was reported the patient sustained a fall.The patient's anatomical condition and its affects on the stability of the construct are unknown contributing factors.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
Follow-up exam ct scans showed the left set screw loose and detached at s1.Patient is asymptomatic.Patient admittedly sustained a fall prior to this event.Surgeon has elected to monitor patient.

• Brand Name: MARINER PEDICALE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM, PRODUCT CODE: NKB
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 7107067
• Report Number: 3012120772-2017-00016
• Device Sequence Number: 16613031
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: 11/27/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR