InjuryHSH
ITOTAL
Received Oct 1, 2014
Report 3004153240-2014-00129 · MDR key 4185991
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Complaint, Ill-Defined
Narrative
Description of Event or Problem
DATA PRESENTED BY DR. (B)(6) IN A CONFERENCE PRESENTATION INDICATED THAT 6 ITOTAL PATIENTS REQUIRED MANIPULATION UNDER ANESTHESIA TO IMPROVE POST-OPERATIVE RANGE OF MOTION. ONE MANIPULATION WAS UNSUCCESSFUL AND THE PATIENT WAS SCHEDULED FOR REVISION FOR ARTHROFIBROSIS.
Additional Manufacturer Narrative
SERIAL NUMBER AND DEVICE MODEL INFORMATION WAS NOT AVAILABLE. INVESTIGATION SPECIFIC TO THE AFFECTED PATIENTS AND DEVICES COULD NOT BE CONDUCTED.