CUSTOMER COMPLAINTS

Complaint Handling Process Instructions

1) 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 Dental Solutions 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.


2) How do I report a product complaint?


When a product complaint is received about a Zest Dental Solutions product please complete the following steps:

  1. Complete Form in Blue or Black ink only
  2. Select appropriate form below, based on the product type:

    Product Type Form to Complete

    Abutments or Ancillary product
    (Examples: processing components, replacement males, etc.)

    PER Form - Abutments PDF Download

    FORM076 Rev H
    PER (Product Experience Report) Form (Abutment)
    Click here to download

    Implants

    PER Form - Implants PDF Download

    FORM158 Rev E
    PER (Product Experience Report) Form (Implants)
    Click here to download

  3. Enter as much information as possible (complete information on relevant FORM, from Step 2). At minimum, please obtain 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

3) Where/how do I send the product after I complete the PER (Product Experience Report) form?


  1. Sterilize the product
  2. Package in appropriately identified plastic bag or equivalent
  3. Attach the PER form
  4. Send to Zest Dental Solutions via reliable carrier (FedEx, UPS, insured USPS) – identify package with PER number if known)

 
Send To:
Zest Dental Solutions
c/o Quality Complaints (PER number, if known)
2875 Loker Avenue East, Carlsbad, CA 92010





4) What happens after Zest Dental Solutions receives the product complaint?


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.



5) How long does it take to process a complaint?


Product complaints will be closed out within 90 days from receipt of the product by Zest Dental Solutions.

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.