|
Seaspine engineering reviewed immediate post-operative and follow-up radiographs and confirmed 3, possibly 4, set screws backed out.Disassociation of the set screw was first noted by the surgeon during the post-operative visit on (b)(6) 2019 and noted subsequent and worsening disassociations on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2020.Throughout the follow up visits, the surgeon noted a stable appearance to the fixation and fusion construct on the radiographs.The assessment was a good early clinical progress, and the recommendation was continued observation.The patient was made aware of the hardware failure and was asked to call the office should his pain worsen.The final assessment was good clinical progress post deformity correction t10 to the pelvis fixation and fusion.Patient described a 99% clinical improvement with normal motor strength in lower extremities.The surgeon achieved significant correction of the spine by anteverting the pelvis to bring the lumber spine back into lordosis.This type of correction places load onto the inferior pedicle screws and rods to hold the correction.Throughout the patient's time fusing and healing, these loads placed on the implants caused them to loosen.As the bottom screws loosened (where the load is highest), the loads were transferred superiorly to cause more connections to loosen and fail.A review of labeling: indications for use: the intended use of the mariner pedicle screw system in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.The indications for use are as follows: degenerative disc disease (ddd) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.E., fracture or dislocation), spinal stenosis, deformities or curvatures (i.E., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis, and/or failed previous fusion.Contraindications: any medical or surgical condition which would preclude the potential benefit of spinal implant surgery is a contraindication.The following conditions may reduce the chance of a successful outcome and should be taken into consideration by the surgeon.This list is not exhaustive: absolute contraindications: infection in or around the operative site, allergy or sensitivity to implant materials, any case not described in the indication.Relative contraindications: local inflammation, morbid obesity, pregnancy, fever or leukocytosis, grossly distorted anatomy, metabolic bone disease, bone absorption, osteopenia, and/or osteoporosis, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (wbc), or a marked left shift in the wbc differential count, patients having inadequate tissue coverage over the operative site.Skeletally immature patient, patient unwilling to cooperate with the postoperative instructions, use with other devices with incompatible materials.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.Postoperative warnings: surgeons should advise patients regarding the risks of surgery and the importance of post-operative compliance.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.The patient should be advised to avoid mechanical vibrations that may loosen the device.The patient should be advised not to smoke or consume alcohol during recovery.
|
