Product Experience Report

Directions: This Electronic Product Experience Report (ePER) form shall be used for all product types (i.e. Implants, surgical instruments, regenerative, and restorative (including Patient Specific) products). Complete steps 1–4 of the form for each event / patient. All fields are required unless stated “as optional”. Submit the completed form, an email will be sent with the submission reference number, a report summary and product return instructions. For questions regarding the ePER form and/or the complaint handling process, you may contact the ZimVie complaint handling unit at DentalComplaints@zimvie.com or 1.800.262.2702. 

Thank you

Thank you for submitting a ZimVie Product Experience Report, your submission has been received and assigned the following reference number:

Now that your submission has been acknowledged, please verify the receipt of your submission within the email account that you provided. Next, print the email response and follow the instructions for returning the complaint product(s) (provided in the email response).

For questions regarding the ePER form and/or the complaint handling process, you may contact the ZimVie complaint handling unit at DentalComplaints@zimvie.com or 1.800.262.2702.

Select a Placement Date or N/A
or
Select a Event Date or N/A
or
Select a Removal Date or N/A
or
Select when the issue was discovered
Description of Event (check all that apply):
Make at least one selection to describe the event Any issue related the restorative product fit.
Make at least one selection to describe the event A titanium hypersensitivity or allergy.
Make at least one selection to describe the event Physiologic or pathologic bone resorption around a dental implant.
Make at least one selection to describe the event A product that is bent.
Make at least one selection to describe the event A product that has a damaged / stripped hex.
Make at least one selection to describe the event A product that has damaged / stripped threads.
Make at least one selection to describe the event Products that do not assemble, connect or engage.
Make at least one selection to describe the event Product that cannot be separated / stuck.
Make at least one selection to describe the event An implant, abutment, screw, instrument or tool fracture.
Make at least one selection to describe the event Dental implant that becomes infected, caused by inflammation of the soft tissue and bone loss around the implant. Abscess and discharge may be present.
Make at least one selection to describe the event The degree of tightness of a dental implant immediately after placement in its prepared osteotomy.
Make at least one selection to describe the event A previously secured product has loosened (i.e. screw loosening).
Make at least one selection to describe the event Loss of contact between living bone and a functionally loaded dental implant surface. Clinical manifestation may include mobility.
Make at least one selection to describe the event Dental implant or drill that may have been drilled too deeply near the inferior alveolar nerve or penetrated the inferior alveolar nerve.
Make at least one selection to describe the event Direct contact between living bone and the dental implant surface does not occur. Clinical manifestation may include mobility.
Make at least one selection to describe the event Any issue related to the labeling or packaging of the product.
Make at least one selection to describe the event Inflammatory reactions in the hard and soft tissues, with loss of supporting bone surrounding a dental implant after functional loading.
Make at least one selection to describe the event The shipping container and contents are damaged.
Make at least one selection to describe the event Tearing or creation of an opening in the maxillary sinus membrane during the preparation of an osteotomy for dental implant placement.
Provide a detailed description of the reported problem (including procedure being peformed, related products and settings used):
Symptoms / Patient Impact: At the time of the event or implant failure/removal, was there …? (Check all that apply):
Make at least one selection to describe symptoms / patient impact at time of event
Make at least one selection to describe symptoms / patient impact at time of event
Make at least one selection to describe symptoms / patient impact at time of event
Make at least one selection to describe symptoms / patient impact at time of event
Make at least one selection to describe symptoms / patient impact at time of event
Make at least one selection to describe symptoms / patient impact at time of event
Make at least one selection to describe symptoms / patient impact at time of event
Make at least one selection to describe symptoms / patient impact at time of event
Was surgical and/or medical intervention necessary to preclude permanent impairment?:
Was intervention necessary?
Was intervention necessary?
Was intervention necessary?
Was there a delay during the procedure?:
Was there a delay during the procedure?
Was there a delay during the procedure?
Was there a delay during the procedure?
Will the patient have to return for an additional dental appointment to complete the procedure?:
Additional appointment required to complete?
Additional appointment required to complete?
Additional appointment required to complete?
Was the procedure completed using another implant or another device?:
Was the procedure completed using another implant or another device?
Was the procedure completed using another implant or another device?
Was the procedure completed using another implant or another device?
Other Relevant Patient History (Check all that apply):
Any other relevant patient history?
Any other relevant patient history?
Any other relevant patient history?
Any other relevant patient history?
Any other relevant patient history?
Any other relevant patient history?
Any other relevant patient history?
Bone Density:
Any Bone Density patient information?
Grafting Information (Optional):
If Site is Grafted, When? (Optional):
Original Product - Product item number is a required field
Original Product - Lot number is a required field
Original Product - Qty is a required field
Will Product Be Returned?:
Original Product - “Will this Product be Returned?” is a required field
Original Product - “Will this Product be Returned?” is a required field
Populate with the product item number, if different than reported device:
Tooth Number:
Destructive Analysis Permitted:
Original Product - “Destructive Analysis Permitted:” is a required field.
Original Product - “Destructive Analysis Permitted:” is a required field.
Relationship to Patient: