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

Model Number	41-1000
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The set screw was not returned for investigation as it remained in-situ and a lot number was not available to review device history records.However, a radiograph was provided, which showed that the set screw was disengaged.The reported allegation of set screw backing out post-operatively was confirmed.A root cause was unable to be determined as the device was not able to be physically evaluated, there were no reported issues with surgical technique, and it is unknown if the patient complied with post-operative warnings, all of which can contribute to post-operative loosening.Review of labeling notes: intra-operative warnings if the system/construct contains screws, prior to soft tissue closure, recheck all screws to ensure they are tightened.Failure to do so may cause loosening of the other components.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.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.It is unknown if the patient sustained a fall.The patient's anatomical condition and the effects on the stability of the implant and/or construct may be unknown contributing factors.
Event or Problem Description
On (b)(6) 2018, the patient underwent a one-level, posterior lumbar fusion using the mariner pedicle screw system.During the one-year follow-up appointment, radiographs were taken, and it was observed that a set-screw had backed-out post-operatively.At the time of contact, a revision surgery had not been performed and it was unknown if the surgeon had plans to revise.There was no report of patient harm or injury.Additional patient information is not available.

• 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: 8913475
• Report Number: 3012120772-2019-00024
• Device Sequence Number: 11139153
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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 Model Number: 41-1000
• Device Catalogue Number: 41-1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR