D
Patient 1
A DOCTOR ALLEGED THAT APPROXIMATELY FIVE (5) PATIENTS HAD EXPERIENCED THE DEBONDING OF A CROWN AFTER PLACEMENT WITH THE MAXCEM ELITE CLEAR PRODUCT. THIS IS THE FIFTH OF FIVE (5) COMPLAINTS.
MAUDE MDR 4055217
- MDR report key
- 4055217
- Report number
- 2024312-2014-00600
- Event key
- 0
- Event type
- 3
- Date received
- 2014-09-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. KERRI CASINO
- Address
- 1717 W COLLINS AVE ORANGE CA 92867 US
- Phone
- 714-714-7145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAXCEM ELITE | DENTAL CEMENT | KERR CORPORATION | MZW | 33872 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-09-03 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
THE PATIENT RETURNED TO THE OFFICE AND THE DOCTOR CLEANED OUT AND RE-CEMENTED THE RESTORATION USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. THE DOCTOR REPORTED THAT HE DID NOT USE THE AUTOMIX TIPS PROVIDED IN THE MAXCEM ELITE PACKAGING AS STATED IN THE DIRECTIONS FOR USE. HE WAS AWARE THAT A NEW TIP IS INTENDED TO BE USED FOR EACH PATIENT; HOWEVER, IN AN ATTEMPT TO SAVE ON "WASTED PRODUCT", HE HAD EXTRUDED THE MATERIAL ONTO A MIXING PAD DIRECTLY FROM THE UNCAPPED SYRINGE AND MIXED THE PRODUCT BY HAND. IT HAS BEEN CONCLUDED THAT THE INTENTIONAL FAILURE TO FOLLOW INSTRUCTIONS WAS THE ROOT CAUSE OF THIS INCIDENT. THE DOCTOR WAS INFORMED BY KERR ON PROPER PRODUCT USAGE.