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:

Country/Region*

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

Alert Important Safety Information

Hear From Someone

Who’s had neck surgery

Prestige LP Complaint Reporting Form Resources

Medtronic Employees or Representatives