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

Model Number	41-6545-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
References two broken screws.This is report 1 of 2.Report #2 is associated with mfr 3012120772-2019-00028.A device history record (dhr) review could not be performed as a lot number was not provided and the screw was not returned for evaluation.X-ray images as well as photos of the broken screws (post revision surgery) were provided, which confirmed the reported allegation.Additionally, x-ray images appeared to show non-union/pseudarthrosis.The interbody implant used for fusion was a non-seaspine product.The root cause was unable to be determined, however, lack of bone fusion that led to patient loads being exerted on mariner screws post-operatively for approximately 8 months is likely a contributing factor.Implants used for fusion were non-seaspine products.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 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) 2018, the patient had the mariner pedicle screw system placed at l4-s1 in adjunct to a non-seaspine interbody implant.On (b)(6) 2019, seaspine was made aware that the patient had experienced two broken solid screws post-operatively, that had been placed bilaterally at s1.X-ray images were provided which showed the screws had broken at the neck.On (b)(6) 2019, the patient underwent revision surgery and the broken screws were replaced.No additional event information was provided.

• 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: 9083977
• Report Number: 3012120772-2019-00027
• Device Sequence Number: 16786092
• Product Code: NKB
• UDI-Device Identifier: 10889981083120
• UDI-Public: 10889981083120
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 41-6545-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2019
• Initial Report FDA Received Date: 09/18/2019
• 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: 66 YR
• Patient Weight: 79