FDA Adverse Event
Injury
Summary report: N
SIMILE
MDR report key: 3182422
·
Received June 21, 2013
Report
- Report Number
- 2024312-2013-00298
- Event Type
- Injury
- Date Received
- June 21, 2013
- Report Date
- June 6, 2013
- Manufacturer
- PENTRON CLINICAL
- Product Code
- EBF
- PMA / PMN Number
- K052106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT HAD EXPERIENCED A DEBONDING OF RESTORATION FOR TOOTH #7 AFTER TWO (2) MONTHS OF PLACEMENT; THE DOCTOR REPLACED THE RESTORATION USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.
Description of Event or Problem · 1
A DOCTOR REPORTED THAT RESTORATIONS HAD DEBONDED AFTER PLACEMENT WITH THE SIMILE COMPOSITE. THIS IS THE FIRST OF THREE (3) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282068 | SIMILE | DENTAL COMPOSITE | EBF | PENTRON CLINICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other| R |