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.

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Description of Event (check all that apply):
Any issue related the restorative product fit.
A titanium hypersensitivity or allergy.
Physiologic or pathologic bone resorption around a dental implant.
A product that is bent.
A product that has a damaged / stripped hex.
A product that has damaged / stripped threads.
Products that do not assemble, connect or engage.
Product that cannot be separated / stuck.
An implant, abutment, screw, instrument or tool fracture.
Dental implant that becomes infected, caused by inflammation of the soft tissue and bone loss around the implant. Abscess and discharge may be present.
The degree of tightness of a dental implant immediately after placement in its prepared osteotomy.
A previously secured product has loosened (i.e. screw loosening).
Loss of contact between living bone and a functionally loaded dental implant surface. Clinical manifestation may include mobility.
Dental implant or drill that may have been drilled too deeply near the inferior alveolar nerve or penetrated the inferior alveolar nerve.
Direct contact between living bone and the dental implant surface does not occur. Clinical manifestation may include mobility.
Any issue related to the labeling or packaging of the product.
Inflammatory reactions in the hard and soft tissues, with loss of supporting bone surrounding a dental implant after functional loading.
The shipping container and contents are damaged.
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):
Was surgical and/or medical intervention necessary to preclude permanent impairment?:
Was there a delay during the procedure?:
Will the patient have to return for an additional dental appointment to complete the procedure?:
Was the procedure completed using another implant or another device?:
Other Relevant Patient History (Check all that apply):
Bone Density:
Grafting Information (Optional):
If Site is Grafted, When? (Optional):
Will Product Be Returned?:
Populate with the product item number, if different than reported device:
Tooth Number:
Destructive Analysis Permitted:
Relationship to Patient: