Contact Details of Complainant
Contact Person First Name *
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Contact Person Last Name *
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Responsible Surgeon *
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Customer First Name *
Please provide your first name

Customer Last Name *
Please provide your last name

Customer Address *
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Please include ZIP code

Contact Email Address *
Please provide your email address

Contact Phone *
Please provide your phone number

Please include area code

Responsible Orthodynamics Product Expert
Please provide your address

If applicable

Patient Information
Patient ID/Initials
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Gender
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Date of Birth
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Body Height
Please provide your state

metres

Body Weight
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kgs

Implantation (Clinic)
Please provide your postcode

Implantation (Date)
Please provide your date of birth

DD/MM/YYYY

Revision (Clinic)
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Revision (Date)
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DD/MM/YYYY

Body Side
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Patient Background
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Event Information
Date of Event
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DD/MM/YYYY

Detailed Event Description
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Are there already any indications of a possible root cause?
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Did the event lead to death of the patient or another involved person?
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Did the event lead to a serious deterioration in state of health of the patient or another involved person?
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Has the event been caused by product failure (opinion of the attending surgeon)?
Please choose your option

Please submit following documents if possible and applicable
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Preoperative planning - prior first implantation; X-Ray first implantation - postoperative; X-Ray Revision - preoperative; X-Ray Revision - postoperative; and/or Surgical report

Product
Product Type
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Other
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Affected Product: Art.-No. (REF)
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Affected Product: SN/LOT - No.
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Affected Product: Description
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Other Involved Product #1: Art.-No. (REF)
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Other Involved Product #1: SN/LOT - No.
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Other Involved Product #1: Description
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Other Involved Product #2: Art.-No. (REF)
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Other Involved Product #2: SN/LOT - No.
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Other Involved Product #2: Description
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Other Involved Product #3: Art.-No. (REF)
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Other Involved Product #3: SN/LOT - No.
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Other Involved Product #3: Description
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Other Involved Product #4: Art.-No. (REF)
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Other Involved Product #4: SN/LOT - No.
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Other Involved Product #4: Description
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Confirmation
All information will be treated confidential. Any disclosure, if required, will be limited to responsible authorities. Thank you very much for your assistance!
Name of Reporting Person
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Date
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DD/MM/YYYY

Report of Findings by Manufacturer
Date Sent to Manufacturer
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DD/MM/YYYY

Date Report Returned
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DD/MM/YYYY

Manufacturer's Comments
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Online Enquiry