Model Number FF530R |
Device Problem
Material Fragmentation (1261)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 07/08/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
|
|
Event Description
|
It was reported that there was an issue with a miaspas tl rongeur.According to the complaint description the device broke during surgery.During a anterior lumbar interbody fusion the working end of the rongeur broke during use.The broken fragments were clearly visible and easily removed.All pieces were retrieved.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).
|
|
Manufacturer Narrative
|
Product has not been received for investigation.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Upon the product received we will report additional results in a supplemental report.
|
|
Search Alerts/Recalls
|