Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Neck Pain (2433)
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Event Type
Injury
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Manufacturer Narrative
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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.Multiple products were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Event Description
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It was reported (in a clinical study) that on (b)(6) 2011, patient underwent anterior cervical discectomy and fusion at c5-c6, c6-c7 levels for treatment of degenerative disc disease where rhbmp-2 was implanted in the patient.Patient had not undergone any previous spinal surgery.On (b)(6) 2011, the patient presented with primary diagnosis of pain behind left ear.The patient was advised to resume wearing neck brace at night.
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Event Description
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It was reported that ae#1 exam date: (b)(6) 2016 diagnostic test: no diagnostic test surgical treatment: no surgical treatment relatedness: not related severity: mild sae: no ae#5 exam date: (b)(6) 2016.Surgical treatment: no surgical treatment relatedness: not related sae: no.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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