SECTION 1: Submitters details
Form completed by

Please provide your full name

(if applicable)

SECTION 2: Complaint information

(e.g. hospital, surgery)

(dd-mm-yyyy)

Unknown?
Event details (please check all that apply) Please select at least on event detail
Alternative device used
Broken instrument
Death
Device revision
Device revision pending
Event occurred due to patient related condition (e.g. osteoarthritis)
Event was preceded by trauma
Intervention to prevent permanent impairment/damage was required
Surgery postponed
Unanticipated serious deterioration in state of health
Other (please specify)

Please include details of usage of device and outcomes attributable to the device, as appropriate.

Date of implantation
Not Applicable?
Unknown?

(dd-mm-yyyy)

Date of explantation
Not Applicable?
Unknown?

(dd-mm-yyyy)

Please use a number betwen 0 and 100

As a result of this event was the surgery time extended?
If "yes", was the time by which the surgery was extended clinically relevant?
Is the item involved in the event still in use?
What was the impact to the patient? (Check all that apply) Please select at least option
Disability or permanent damage
Extended hospitalisation
Frequency of patient monitoring increased
Not involving a patient
Patient(s) recalled for unscheduled check
Revision surgery required
There was no impact to the patient
Other (please specify)

SECTION 3: Device information

(bar code digits on shelf carton)

Is device available to be returned to Corin?
SECTION 4: Associated device information
Device 1

(bar code digits on shelf carton)

Is device available to be returned to Corin?
ADD Device
SECTION 5: Additional information
File attachments

(Please note there is a 15MB limit per file and a total limit of 30MB)

Attachment 1

Attachment 2

Attachment 3

Attachment 4

Attachment 5

Are other relevant documents attached? (e.g. medical notes)

RA FRM 002
Revision: 03

Effective Date: 05 Jun 18
CR: 154