WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMP IMPL KIT 20X20X20 2 LEGS; STAPLE, FIXATION, BONE
|
Back to Search Results |
|
Model Number EL-2020S2 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 01/01/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Exact date of event is unknown; event occurred sometime between the original implant procedure on (b)(6) 2021 and the revision procedure on (b)(6) 2021.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that on (b)(6) 2021, the patient underwent a removal surgery of the 20/20 elite compression implant due to implant failure after a gynecology procedure.When the patient was moved into stirrups, the open-book pelvic reduction was lost.The initial surgery was done on (b)(6) 2021.The revision surgery was completed with a 6.5 mm cannulated screw and a 145 mm drill bit.The outcome of the procedure was good.This report is for an elite compression implant.This is report 1 of 1 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|