PROVIDENCE MEDICAL TECHNOLOGY, INC. CAVUX CERVICAL CAGE-B; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
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Model Number PD-31-200 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Neck Pain (2433)
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Event Date 05/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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A (b)(6)-year-old male underwent posterior cervical fusion surgery on (b)(6) 2020 with cervical cages placed bilaterally posteriorly at c4-c5, c5-c6, c6-c7.Patient is a smoker and has history of previous cervical spinal surgery; procedure was to address pseudarthrosis from previous surgery.All six cervical cages were implanted successfully but a note was made about difficulty to access facet joint due to patient anatomy and previous surgery.Approximately 3 weeks later, patient complained of right side pain prompting imaging to be taken.Imaging suggested cervical cages placed on the right side may be mal-positioned, potentially causing patient pain.A revision surgery was performed (b)(6) 2020 to remove all three cervical cages placed on the right side (c4-c7) and replace with lateral mass instrumentation.No device defect or malfunction was reported.Patient is recovering as expected.
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Event Description
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A (b)(6)-year-old male underwent posterior cervical fusion surgery on (b)(6) 2020 with cervical cages placed bilaterally posteriorly at c4-c5, c5-c6, c6-c7.Patient is a smoker and has history of previous cervical spinal surgery; procedure was to address pseudarthrosis from previous surgery.All six cervical cages were implanted successfully but a note was made about difficulty to access facet joint due to patient anatomy and previous surgery.Approximately 3 weeks later, patient complained of right side pain prompting imaging to be taken.Imaging suggested cervical cages placed on the right side may be mal-positioned, potentially causing patient pain.A revision surgery was performed on (b)(6) 2020 to remove all three cervical cages placed on the right side (c4-c7) and replace with lateral mass instrumentation.No device defect or malfunction was reported.Patient is recovering as expected.
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