Prestige LP Complaint Reporting Form Resources

I am a Physician
Patient
Medtronic Employee or Representative
Other Healthcare Professional

Reason for Inquiry

Facility Information

Hospital/Facility Name

Hospital/Facility Address

Surgeon First Name

Surgeon Last Name

Was the surgeon involved in the US IDE clinical trial (ClinicalTrials.gov Identifier: NCT00667459)?

Device Information

Please select what your complaint is related to:

Please select the instrument category your product problem and/or adverse event is related to:

Was the implant/instrument used in a patient?

Was the implant/instrument prepared per labeling?

Were there patient complications related to your product problem and/or adverse event?

Implant Part Number/Size Used

Lot number(s) of implant/instrument related to product problem and/or adverse event

Initial Surgery Date

Levels Treated

Event Information

Product problem and/or adverse event date (NOTE: if this is a post-op event, the event date may be prior to the date of revision surgery)

When did the product problem and/or adverse event event occur?

Was the implant/instrument related to your product problem and/or adverse event returned to Medtronic?

Description of the product problem and/or adverse event including details on adverse event type including serious injury, device malfunction, secondary surgical procedure, etc. (limit 5,000 characters)

Images such as MRI, CT, x-ray, etc. and/or medical records available? If yes, a Medtronic employee will contact you to request copies of patient images and/or medical records

Did heterotopic ossification (HO) occur?

Patient Information

Patient identifier (clinical ID, initials)

Patient age at product problem and/or adverse event

Patient gender Male
Female
I do not know

Patient weight

Patient ethnicity

Relevant patient medical history, including pre-existing conditions, previous surgeries, etc. and any co-morbidities including alcohol use, tobacco use, medical conditions: (limit 10,000 characters)

Initial patient diagnosis

Treatment and/or follow-up action provided (and dates) attributed to product problem and/or adverse event including explant, revision, reoperation, secondary surgery, etc. (limit 5,000 characters)

Patient outcomes (and dates) attributed to product problem and/or adverse event including death, life-threatening disability/permanent damage, hospitalization, other serious medical events, intervention required class="required" (After follow-up actions taken):

Reporter Information

Your First Name:

Your Last Name:

Your email (for confirmation of submission):

Confirm your email address:

I have answered the questions to the best of my knowledge and abilities.

Prestige LP Complaint Reporting Form Resources

MDT Employees or Representatives

Talk to Someone