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

Catalog Number 41-1000

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 01/25/2017

Event Type  malfunction  

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 Description

Initial surgery was performed from in (b)(6) 2017 and patient was instrumented with poster fixation.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: aaron ; 5770 seaspine drive; carlsbad, CA 92008
• MDR Report Key: 7741016
• MDR Text Key: 115777681
• Report Number: 3012120772-2018-00015
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR