X-ray images that identified loosening of the implant construct were not provided for the complaint investigation.A revision procedure was performed on (b)(6) 2020.There were no reported complications or delay in treatment associated with the revision procedure.On (b)(6) 2020 a response from the complainant, who identified that in addition a migrated locking cap, the system rod and interbody spacer had migrated resulting in a patient dura tear.It may be possible for a locking cap to migrate from the original procedure implant construct location if the torque applied to the locking cap was not enough for appropriate final locking.The company confirmed that the torque limiting handles that were used during the original procedure effectively limited applied torque as intended.A locking cap could become loose and migrate if the implant construct was subjected to inordinate stress prior to maturation of the fusion mass was confirmed.Through the course of the investigation, the complainant also reported that the system rod and interbody spacer had migrated resulting in a patient dura tear.If any component of an implant construct becomes loose, it may allow shifting/loosening of other implant components resulting in implant migration.The potential complications and adverse effects section of the pedicle screw ifu includes early or late loosening of the components; disassembly, bending or breakage of any or all of the components; non-union (pseudarthrosis); and dural tears.The potential complications and adverse effects section of the interbody spacer ifu includes early or late loosening of any or all of the components; dural tears, persistent csf leakage, meningitis; non-union (pseudarthrosis), and delayed union, mal-union.
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The company received notification of (b)(6) 2020 from a surgical facility, that reported during a patient's routine eight-month follow-up an implant locking cap was identified as having migrated since the original procedure.The original l5-s1 decompression and fusion with pedicle screws and interbody spacer was performed on (b)(6) 2020 due to personal injury.There were no known patient complications identified during the original procedure.The health status of the patient was reported as, "patient's general health is well.However, patient is experiencing great pain when standing, sitting, and walking." the following reports are associated with this submission: 3005031160-2020-00023.3005031160-2020-00027.
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