MAUDE Adverse Event Report: SEASPINE INC. SEASPINE MARINER PEDICLE SCREW SYSTEM; SOLID SCREW 8.50 X 45MM

Model Number 41-8545-1

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

The 41-8545-1 solid screws 8.50 x 45mm lot aw70944b were returned for investigation and evaluated by engineering on 24 aug 2020.The returned screws are fractured at the neck of the screw, originating where the major diameter of the bone thread terminates, which is the expected fracture location.The observed fracture is a result of chronic non-union.The implants are intended to be temporary fixation devices to hold the spinal correction while the patient fuses.If the patient does not fuse, the implants will be required to hold all the load and will eventually fail.The screw shanks were noted to be broken 2+ years from the index surgery; generally fusion is expected to occur within 6-10 months.The root cause appears to be related to patient factors (chronic non-union/pseudarthrosis); the patient's inability to fuse caused excessive load to be placed on the fixation components and overall construct.Review of labeling: possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: 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 pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin.Dural leak requiring surgical repair.Cessation of growth of the fused portion of the spine.Subsidence of the implant into adjacent bone.Loss of proper spinal curvature, correction, height and/or reduction.Increased biomechanical stress on adjacent levels.Improper surgical placement of the implant causing stress shielding of the graft or fusion mass.Intraoperative fracture, or perforation of the spine.Postoperative fracture due to trauma, defects, or poor bone stock.Serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism, or death.Warnings and precautions: patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without previous surgery.The safety and effectiveness of spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation.These conditions are significant mechanical instability or deformity of the spine secondary to severe spondylolisthesis, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).The safety and effectiveness of these devices for any other condition is unknown.The implantation of this system should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient.The surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the system.Ensure all implants, components or instruments are sterilized prior surgery.The use of non-sterile devices may lead to inflammation, infection or disease.Implants should never be reused under any circumstances.A used implant should be discarded.While the implant may appear undamaged, it may have small defects or internal stress patterns and if implanted, could fail to perform as intended and pose safety risks to the patient.The risks include, but are not limited to, mechanical failure, breakage, difficulty with implantation, incompatibility with mating components and infection.

Event Description

The patient underwent spinal surgery l4-s1 on (b)(6) 2018 which consisted of seaspine's mariner pedicle screw system.It was reported that the patient had a chronic non-union/pseudarthrosis.The surgeon elected to supplement the posterior fixation by performing an alif (non-seaspine product) on (b)(6) 2019.It was later noted that two mariner screws fractured at l5 which led to a revision surgery on (b)(6) 2020 to remove the mariner screws and reinstrument the construct.

• Brand Name: SEASPINE MARINER PEDICLE SCREW SYSTEM
• Type of Device: SOLID SCREW 8.50 X 45MM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, ca ; 2165137
• MDR Report Key: 10468620
• MDR Text Key: 205543621
• Report Number: 3012120772-2020-00067
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981069476
• UDI-Public: 10889981069476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 41-8545-1
• Device Catalogue Number: 41-8545-1
• Device Lot Number: AW70944B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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