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

Catalog Number	41-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A case/charge sheet was received to identify part number and patient information.It is unknown the nature of the alleged failure.It is unknown if revision surgery was preformed.Patient's current condition is unknown.Dhr review and product investigation cannot be completed, as multiple attempts have been made to recover the product and/or product information.It is unknown if the patient complied with post-op care instructions.The patient's activity level will dictate the longevity of the implant.Review of labeling notes: "possible adverse events: 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, as multiple attempts have been made to acquire additional information to no avail.No conclusions can be drawn.
Event or Problem Description
Initial surgery was performed from in (b)(6) 2017 and patient was instrumented with poster fixation.

• 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: 7741016
• Report Number: 3012120772-2018-00015
• Device Sequence Number: 1040836
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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 Catalogue Number: 41-1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2018
• 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: 67 YR