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

Model Number 99-1024-12

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

This is report 2 of 2.Report #1 is associated with mfr 3012120772-2019-00030.A device history record (dhr) review could not be performed as a lot number was not provided and the implants were not returned for evaluation.A radiograph and photo of the explanted implants were provided for review.The reported event of loosened implants was confirmed via radiograph.A root cause was unable to be determined, however, as implants were not able to be physically inspected, measured or functionally tested and there was no indication of inadequate surgical technique or patient failure to follow post-operative care instructions.A supplemental report will be filed should additional information become available.Review of labeling notes: possible adverse events: like other spinal system implants, the following adverse events are possible: delayed union or nonunion (pseudarthrosis).Bending, disassembly or fracture of implant and components.Loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain, discomfort, or abnormal sensations due to the presence of the device.Postoperative warnings: the patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation.The patient should be advised that implants may bend, break or loosen despite restriction in activity.

Event Description

On (b)(6) 2019, the patient had the mariner outrigger revision system implanted.Patient subsequently complained of clicking noises and a burning feeling while walking or with flexion/extension movements.On (b)(6) 2019, a revision surgery was performed as it was found that two of the implants had loosened post-operatively.At the time of this report, no additional patient or event information had been provided.

• Brand Name: MARINER OUTRIGGER REVISION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: stephanie chavez ; 5770 armada drive; carlsbad, CA 92008 ; 7602165109
• MDR Report Key: 9328903
• MDR Text Key: 166582392
• Report Number: 3012120772-2019-00031
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981184964
• UDI-Public: 10889981184964
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99-1024-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR