Catalog Number UNK_ORM |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Pain (1994)
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Event Date 02/11/2016 |
Event Type
Injury
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Event Description
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It was reported that patient had a vertebroplasty and since the surgery, she has been experiencing excruciating pain brought on by light movement.Patient wants to know if she has any allergy to the product.Her quality of life has suffered in that she can no longer drive or stand for long periods of time.She is currently seeing another orthopedic surgeon, neuroradiologist, a doctor for pain management/intervention and her primary physician as well as other doctors who she doesn't want to disclose as of yet.Patient asked not to contact her doctors until she speaks with them.
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Manufacturer Narrative
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Method: risk assessment; results: device history, device evaluation, and complaint history review could not be performed as the device was not properly identified.Conclusion: the root cause could not be determined conclusively as no device and/or insufficient information was received.
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Event Description
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It was reported that patient had a vertebroplasty and since the surgery, she has been experiencing excruciating pain brought on by light movement.Patient wants to know if she has any allergy to the product.Her quality of life has suffered in that she can no longer drive or stand for long periods of time.She is currently seeing another orthopedic surgeon, neuroradiologist, a doctor for pain management/intervention and her primary physician as well as other doctors who she doesn't want to disclose as of yet.Patient asked not to contact her doctors until she speaks with them.
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Search Alerts/Recalls
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