FDA Adverse Event
Injury
Summary report: N
MAXCEM ELITE
MDR report key: 2883305
·
Received December 21, 2012
Report
- Report Number
- 2024312-2012-00316
- Event Type
- Injury
- Date Received
- December 21, 2012
- Report Date
- November 28, 2012
- Manufacturer
- KERR CORPORATION
- Product Code
- EMA
- PMA / PMN Number
- K073209
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR ALLEGED THAT THE PATIENT HAD EXPERIENCED A LOOSE CROWN ON TOOTH #18 APPROXIMATELY ONE (1) MONTH AFTER PLACEMENT. THE CROWN WAS REMOVED AND THEN RE-CEMENTED WITH THE MAXCEM ELITE CLEAR PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED ISSUES INVOLVING THE ADHESION OF THEIR CROWNS APPROXIMATELY ONE (1) MONTH AFTER PLACEMENT WITH MAXCEM ELITE CLEAR. THIS IS THE SECOND OF TWO (2) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXCEM ELITE | CEMENT, DENTAL | EMA | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | MONO BOND |