Catalog Number DWJ505 |
Device Problems
Positioning Problem (3009); Difficult or Delayed Separation (4044)
|
Patient Problem
No Code Available (3191)
|
Event Date 05/21/2019 |
Event Type
malfunction
|
Event Description
|
It was reported that during implantation, dr.(b)(6) found that the 6.5 mm diameter central screw was too thin.Therefore, she wanted to replace this screw with a diameter of 9.5 mm.The 6.5 mm screw could not be removed from the baseplate (left-hand thread was considered).Surgery time was extended by over 60 minutes.
|
|
Manufacturer Narrative
|
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.
|
|
Event Description
|
It was reported that during implantation, dr.Schulz found that the 6.5 mm diameter central screw was too thin.Therefore, she wanted to replace this screw with a diameter of 9.5 mm.The 6.5 mm screw could not be removed from the baseplate (left-hand thread was considered).Surgery time was extended by over 60 minutes.
|
|
Search Alerts/Recalls
|