CALIBRA VENEER KIT W/P&B XP
Received Mar 26, 2022
Report 2515379-2022-00041 · MDR key 13919335
Device
Product problems
- Unexpected Color
- Material Discolored
- Unexpected Color
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT CALIBRA VENEER KIT W/P&B XP HAS DISCOLORED/TURNED BLACK IN THE AREA WHERE PLACED. DEVICE BEING RETURNED.
Additional Manufacturer Narrative
WHILE THERE IS NO INDICATION THAT SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Additional Manufacturer Narrative
INVESTIGATION/INSPECTION FOUND: APPEARANCE (RETURN) - PASSCOLOR - PASS. DHR REVIEW - PASS. APPEARANCE (RETAIN) - PASSCOLOR - PASS. NO DEFECT PROVEN - NO FAILURE FOUND.