Outcomes attributed to adverse event: other : nerve damage.Although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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The information was received from social media via a manufacturing representative regarding a patient with spinal therapy.It was reported that the surgeon used a morphogenic synthetic bone growth protein chemical on the patient, and was found to be highly caustic and inflammatory, causing significant nerve damage.Clinical trials were falsified.There was no further information reported.
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