Model Number SD980.001 |
Device Problems
Difficult or Delayed Positioning (1157); Inadequacy of Device Shape and/or Size (1583)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 09/16/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation is ongoing.Device not yet explanted.
|
|
Event Description
|
After the surgery, it was found that the occlusion was off and that this resulted in the patient having an over bite.Surgeon is discussing with patient whether to have a revision surgery or not.
|
|
Manufacturer Narrative
|
Investigation concluded that the bad occlusion was caused by a user error by the surgeon, who did not follow the instructions.The surgeon did not place a graft which was planned to be placed.This caused the maxilla to move when forces were applied.Splint and guides were discarded by surgeon, plates still in patient only fields that have additional information have been completed, all other fields are kept empty as they were reported in the initial report and still correct.
|
|
Event Description
|
After the surgery, it was found that the occlusion was off and that this resulted in the patient having an over bite.Surgeon did coronoidectomy in week 45 and will do revision surgery when patient returns to town in 6 months.
|
|
Search Alerts/Recalls
|