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Catalog Number UNK_SPN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2023 |
Event Type
Injury
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Event Description
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The article 'the surgical outcome of multilevel anterior cervical discectomy and fusion in myelopathic elderly and younger patients' in scientific reports, volume 12 (4495) 2022, was reviewed.Consecutive patients with degenerative cervical myelopathy treating by primary multilevel acdf (3 or more levels) and plate fixation by a single surgeon from january 2006 to september 2019 were retrospectively reviewed.Postoperative events were recorded including nonunion, cage subsidence, implant loosening, pseudoarthrosis, surgical site infection, adjacent segment pathology, revision surgery as surgical related and pneumonia, sepsis, kidney failure, cerebrovascular accident, myocardial infarction as medical disease related.These complications were grouped into short-term as occurrence within 1 year and middle-term as occurrence more than 1 year.The surgical complications were further categorized as need to have reoperation or not.A total of 63 patients including 45 males and 18 females were studied.Multilevel acdf was performed at three level in 49 patients, four-level in 13 patients and five-level in 1 patient.Patients were implanted with the reflex hybrid plate system.This report captures one patient who experienced "deep surgical site infection" approximately one-year after index surgery.The patient underwent debridement and removal of implant.
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Manufacturer Narrative
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Device location unknown.
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Manufacturer Narrative
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H6 coding has been updated to reflect completion of the investigation.
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Event Description
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The article 'the surgical outcome of multilevel anterior cervical discectomy and fusion in myelopathic elderly and younger patients' in scientific reports, volume 12 (4495) 2022, was reviewed.Consecutive patients with degenerative cervical myelopathy treating by primary multilevel acdf (3 or more levels) and plate fixation by a single surgeon from (b)(6) 2006 to (b)(6) 2019 were retrospectively reviewed.Postoperative events were recorded including nonunion, cage subsidence, implant loosening, pseudoarthrosis, surgical site infection, adjacent segment pathology, revision surgery as surgical related and pneumonia, sepsis, kidney failure, cerebrovascular accident, myocardial infarction as medical disease related.These complications were grouped into short-term as occurrence within 1 year and middle-term as occurrence more than 1 year.The surgical complications were further categorized as need to have reoperation or not.A total of 63 patients including 45 males and 18 females were studied.Multilevel acdf was performed at three level in 49 patients, four-level in 13 patients and five-level in 1 patient.Patients were implanted with the reflex hybrid plate system.This report captures one patient who experienced "deep surgical site infection" approximately one-year after index surgery.The patient underwent debridement and removal of implant.
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Search Alerts/Recalls
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