D
Patient 1
A DOCTOR'S OFFICE ALLEGED THAT SEVEN (7) PATIENTS HAD EXPERIENCED THE DEBONDING OF A FIBREKOR FIBER POST WITH THE CORE AND CROWN STILL ATTACHED. THIS IS THE SIXTH OF SEVEN (7) REPORTS.
MAUDE MDR 3836884
- MDR report key
- 3836884
- Report number
- 2024312-2014-00424
- Event key
- 0
- Event type
- 3
- Date received
- 2014-05-28
- 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 WEST COLLINS AVENUE 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 | FIBREKOR POST | ROOT CANAL POST | PENTRON CLINICAL | ELR | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-05-28 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
PATIENT INFORMATION WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. A NEW POST AND CORE WAS CREATED FOR THE PATIENT. THE DOCTOR RETROFITTED THE NEW POST AND CORE TO THE ORIGINAL CROWN AND CEMENTED IT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER OR CATALOG NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.