SYNTHES USA 5.0MM CANNULATED VA LOCKING SCREW/60MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
|
Back to Search Results |
|
Catalog Number 02.231.660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Burn(s) (1757)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient¿s information is not available for reporting.Event date: the exact date of the postoperative event is unknown; however, it reportedly occurred two (2) to three (3) weeks after the initial procedure.Explant date: devices have not been explanted.Initial reporter: hospital contact pager number (b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 a patient underwent a surgical procedure on (b)(6) 2015 during which a distal femur plate, screws, and cable was implanted to treat a femur fracture.(a competitor's osteobiological product was implanted as well.) no surgical delay was reported for this procedure.Approximately two (2) to three (3) weeks postoperative, a magnetic resonance image (mri) was performed.As a result, the patient sustained a burn.This report is 7 of 10 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|