Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Bone Fracture(s) (1870)
|
Event Type
Injury
|
Manufacturer Narrative
|
Literature article citation: toshiaki kotani et al."balloon kyphoplasty and clinical pathway for osteoporotic vertebral fractures" mean age(77.2 years) female( 7 men and 35 women) neither the product nor applicable imaging films were returned to manufacturer for evaluation therefore definitive cause of event cannot be determined.
|
|
Event Description
|
It was reported that a total of 42 patients whose pain did not greatly improve with conservative treatment underwent balloon kyphoplasty from (b)(6) 2012 to (b)(6) 2013.As postoperative complication, re-fracture was seen in 11 patients.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|