Complaints Form

Complaints V0.1

Contact Information

If Additional information is needed regarding this event, follow-up questions will be sent to the reporter. If questions should be directed to someone else, please provide below:

Hospital/Complaint Information

Product Information

Will the Device be Returned for Evaluation?
Add/Remove Product
If the product cannot be returned, please provide rationale
RMA NEEDED?

Event Information

date of report or date Integrity Implants became aware of event
Include information on impact to the patient or user and/or malfunction, if known
Did the device fail to perform as expected?
Did the event occur during a surgery?

Maximum file size: 134.22MB

e.g. prior to surgery, outside of operation room, with the distributor or site etc.
Type of procedure performed:
Was there a death or impact to the patient?
Clearly Describe:
Was there a medical intervention?
e.g. revision surgery, additional treatment, prescribed medication, additional appointments to see medical professional, etc.
Did the event cause a delay to the procedure?
Was another of the same device available in the OR to complete the procedure?
(e.g. another similar device available in the OR with the same intended use)
Were there any contributing conditions related to the event?
e.g. trauma, illness, previous surgery, related non-compliance, patient anatomy, infection, etc.
Was the surgical technique for the product utilized?
For an instrument/ implant fracture, did any pieces fall into the patient?
Were all pieces retrieved?

Patient Information

Gender:
Ethnicity:
Race:

No Additional Information

When and by whom was it communicated to you that there is no additional information or documents available?
*Please note: You will be contacted if information is not complete or marked “UNK” and the above sectionis not confirmed and filled in.