SURGEON FEEDBACK FORM
HEALTH PROVIDER INFORMATION
Name
Email Id
Company/Hospital Name
Phone/Contact No.
DEVICE INFORMATION
Device / Product Name
Product Code
Batch/Lot Number
USER EXPERIENCE (✓/ ✕)
Easy to Use
Easy to Handle
Surgical Technique Guide is useful
CLINICAL MALFUNCTION (SAFETY AND PERFORMANCE OF THE DEVICE)
Did Patient/Device faced any issue/malfunction/injury/Adverse Events due to Auxein’s Implant?
Yes
No
When did issue/malfunction/injury occur?
Characterization of device problem
IF ANY OF THE FOLLOWING POTENTIAL ADVERSE EVENTS OCCUR TO THE PATIENT, THEN PLEASE CHECK OF (✓) THAT POTENTIAL ADVERSE EVENT.
Severe Pain
Non Union
Screw Back out
Infection
Revision Surgery
Screw Threat Shear
Irritation
Loss of Reduction
Delayed Union
Mal Union
Malalignment
Corrosion
Stress Shielding
Amputation
Lateral Migration
Deep Vein Thrombosis
Screw Breakage
Metal Sensitivity
Nerve Injury
Screw Loosening
Compartment Syndrome
Implant Removal
Device Slipped
Detachment of Device
Issue in Pulling/Flipping
Screw Head Stripped
Failure to Fire
Suture Breakage
Construct Failure
Discomfort
Any Other
(Please Elaborate in below given Remark Section)
REMARK
OVERALL DEVICE SAFETY/PERFORMANCE (✓/ ✕)
Note:
✓ Means: Device is good to be used for treating Fracture of bone / Fixation of Ligaments or Tendon.
✕ Means: Device is not safe to be used for treating Fracture of bone / Fixation of Ligaments or Tendon.
Patient Safety
Ease of Implantation
Device Performance
Device Quality
Device Compatibility with Instrument
Date:
Location:
Signature of Physician/Doctor/Intended User:
Submit
