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

Model Number	99-1024-12
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 9328903
• Report Number: 3012120772-2019-00031
• Device Sequence Number: 13921488
• Product Code: NKB
• UDI-Device Identifier: 10889981184964
• UDI-Public: 10889981184964
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 99-1024-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR