Catalog Number UNK_SEL |
Device Problem
Mechanics Altered (2984)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 06/17/2015 |
Event Type
malfunction
|
Event Description
|
During variax clavicle surgery, the surgeon bent the plate to adjust it to the shape of the bone.When the surgeon inserted the locking screw in screw hole of the plate, the locking screw didn't lock.Therefore the locking screw was inserted in different screw hole, but the locking screw didn't lock.The surgeon changed the plate to another plate.
|
|
Manufacturer Narrative
|
Unknown locking screw.Once the investigation has been completed any additional information will be reported in a supplemental report.
|
|
Manufacturer Narrative
|
The reported incident could not be confirmed, since the device was not returned for evaluation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|
|
Event Description
|
During variax clavicle surgery, the surgeon bent the plate to adjust it to the shape of the bone.When the surgeon inserted the locking screw in screw hole of the plate, the locking screw didn't lock.Therefore the locking screw was inserted in different screw hole, but the locking screw didn't lock.The surgeon changed the plate to another plate.
|
|
Search Alerts/Recalls
|