inforMED
InjuryEMA

SUREFIL ONE INTRO KIT

Received Feb 2, 2023

Report 8010638-2023-00018 · MDR key 16283030

Device

Generic name

Cement, Dental

Catalog number

60300200

Lot number

2101000496

Product problems

  • Loss of or Failure to Bond

Patient

Unknown

  • Failure of Implant
  • No Clinical Signs, Symptoms or Conditions
  • Failure of Implant
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

INVESTIGATION FOUND: THE DEVICE/MATERIAL EXPIRED. ROOT CAUSE: OUT OF LIFETIME. CONCLUSION CODE: SERVICE LIFE OR SHELF LIFE EXCEEDED.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT SUREFIL ONE INTRO KIT THAT WAS USED REPORTEDLY FELL OUT - DEBONDED. DOCTOR STATED THEY HAD SOME SUREFIL ONE MATERIAL THAT THEY INITIALLY USED AND HAD SOME DEBONDING. HE STATED THAT THE MATERIAL IS NOW EXPIRED AND BEEN THROWN OUT BUT HE HAD A LOT NUMBER SAVED FOR US. NO INJURIES TO PATIENTS.

Additional Manufacturer Narrative

WHILE NO 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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.