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Catalog Number C01A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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Although it is unknown whether this 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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Event Description
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Pre-op diagnosis: primary osteoporosis type of fracture: compression fracture procedure: balloon kyphoplasty (bkp) levels implanted: l2 it was reported in a post-market study that the patient complained of back pain after the surgery and subsequent follow-up visits on the seventh day, first month, six months and twelve months post-surgery.The patient had a history of spinal fracture at l3 and l4.The patient was hospitalized on (b)(6) 2011 and discharged on (b)(6) 2011.
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Search Alerts/Recalls
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