Catalog Number KX203-C |
Device Problems
Misconnection (1399); Material Puncture/Hole (1504)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/24/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This part is not approved for use in the united states; however a like device catalog # kx203, 510k # k101864 and udi # (b)(4) was cleared in the united states.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.
|
|
Event Description
|
It was reported that the patient was diagnosed with compression fracture at l2; and underwent balloon kyphoplasty.Intra-op, while performing the procedure, the surgeon noticed a leakage on x-ray while he started to inflate balloons inside the patient vertebral body.When he tried to replace the balloon, all the available inflatable bone tamps (ibts) in the stock of the hospital were already pierced in the packaging.As all available ibts were defective, it was impossible to perform the planned balloon kyphoplasty.Hence, simple vertebroplasty was performed.No patient complications were reported due to this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
After the sales rep collected the alleged product from the hospital and checked the product himself, he found that the product was not defective at all.The inflatable bone tamp (ibt) worked pretty well.It was determined that the nurse had not connected the pump to the blue connector of the ibt; and instead, she removed the inner stylet of the ibt and plugged the pump on it.Because of this bad connection, she was unable to inflate the ibt and the water directly came out the edge of the ibt.The surgeon and the 'or' manager agreed with the sales rep's observation.
|
|
Search Alerts/Recalls
|