Complaint Handling Process

WHAT IS A PRODUCT COMPLAINT?

A product complaint can encompass any product Zest Dental Solutions manufactures such as hardware, processed materials, labeling and informational literature. If the product is incorrect, has not performed as expected or in another way not met your expectations or that of your patient(s), please notify Zest Dental Solutions. The Food and Drug Administration defines a complaint as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Please note: If one of our products has injured (death, serious injury or malfunction) one of your patients, Zest is obligated to notify the FDA of such an incident via the Medical Device Reporting Regulation within 30 calendar days from Zest becoming aware of an event.

HOW DO I REPORT A PRODUCT COMPLAINT?

When you have a product complaint about a Zest Dental Solutions Product please complete the following steps:

  1. Select appropriate Product Experience Report (PER) based on the product type (please refer to graph below)
  2. Complete Report in Blue or Black ink only
  3. Enter as much information on the PER as possible. At minimum, please list the following:
  • Product Code / Part Number
  • Lot Number (if known)
  • Date of Placement
  • Date of Event
  • Date of Removal
  • Description of Complaint / Incident
  • Any additional details regarding the incident
  1. Sterilize the product
  2. Package in appropriately identified plastic bag or equivalent
  3. Attach the PER form
  4. Date of Event
  5. Send via reliable carrier (FedEx, UPS, insured USPS) to: Zest Dental Solutions c/o Quality Complaints (include PER number, if known) 2875 Loker Avenue East, Carlsbad, CA 92010. Once the product has been received it will be assigned a PER #, and will be evaluated by our Quality Team to determine the probable cause of the reported complaint/incident.
Product Type Form To Complete Download PDF
Abutments or Ancillary product (Examples: processing components, replacement males, etc.) FORM076 Rev J PER (Product Experience Report) Form (Abutment)
Implants FORM158 Rev F PER (Product Experience Report) Form

COMPLAINT PROCESSING

General product complaints will be closed within 90 days Zest Dental Solutions from receipt of the product. Dental Implant complaints will be closed within 30 days of the awareness date. Closure letters will be sent to customers upon request. If no product is received from the customer within 60 days from the date of notification, the complaint will be closed.