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.Although it is unknown whether this product caused or contributed to the reported event, we are filling this mdr for notification purpose.If information is provided in the future, a supplemental report will be issued.
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It was reported via social media post that on an unknown date, the patient underwent lumbar surgery via posterior and/or lateral approach.She was implanted with rhbmp-2/acs in this surgery.On an unknown date, 5 months post-op, the patient had severe pain due to which she could not get out of her bed.Allegedly, she experienced pain that was far worse than it ever was prior to surgery.Reportedly, before surgery, her pain was limited to her low back; but now she had been experiencing nerve pain that originates from the lateral incision in her left side and radiates all the way down to her knee.In addition to that, at times the nerves in her left foot did not respond properly and walking was next to impossible.
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