Treatment description: removal of posterior segmental instrumentation l2-s1, posterior arthrodesis l5-s1 and s1 to ilium with bone morphogenic protein and allograft, new posterior segmental instrumentation l2-ilium.No information known related to potential comorbidities, falls/impacts.Outcome: patient recovered well.Review of labeling: indications for use: accell evo3® is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure.The product is indicated for use as a bone graft extender in the spine, extremities and pelvis.Accell evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis.The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.Description: accell evo3 is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium.Accell evo3 is formulated into a putty form and is provided in a sterile, single use package.As a biological material, some variations in the product should be expected, such as in appearance and handling.Postoperative care: postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting.Standard postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation devices.The patient should be cautioned against early weight bearing and premature ambulation that could lead to loosening and/or failure of the fixators or loss of reduction.The length of time a defect should remain in a reduced state of loading is determined by the complexity of the defect site and the overall physical condition of the patient.Hardware should not be removed until the defect is healed.Potential adverse events: surgical procedures involving implantation of bone grafts are associated with the following risks: superficial wound infection, deep wound infection with or without osteomyelitis, nonunion, delayed union and/or malunion, wound dehiscence, loss of reduction, refracture, cyst recurrence, hematoma, cellulitis.
|
The patient underwent spinal surgery on (b)(6) 2017, which consisted of posterior fixation using nuvasive's reline system, an unknown implant cage manufactured by amedica, and seaspine's accell evo3 demineralized bone matrix.Seaspine was made aware on 10 jul 2020 of a fractured 5.5 mm cobalt chrome rod that occurred or was discovered on or around (b)(6) 2017.
|