FDA Adverse Event
Injury
Summary report: N
MAXCEM ELITE
MDR report key: 2900642
·
Received January 7, 2013
Report
- Report Number
- 2024312-2013-00033
- Event Type
- Injury
- Date Received
- January 7, 2013
- Report Date
- December 10, 2012
- Manufacturer
- KERR CORPORATION
- Product Code
- EMA
- PMA / PMN Number
- K073209
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
SPECIFIC PATIENT OR INCIDENT INFORMATION WERE NOT PROVIDED BY THE DOCTOR. TO DATE, THE PATIENT IS DOING FINE; A NEW CROWN WAS RE-CEMENTED USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. THE PRODUCT WAS NOT RETURNED AND NO ITEM NUMBER OR LOT NUMBER WERE PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT APPROXIMATELY THIRTY (30) PATIENTS EXPERIENCED THE LOSS OF A CROWN APPROXIMATELY SIX (6) MONTHS TO ONE (1) YEAR AFTER PLACEMENT WITH MAXCEM ELITE. THIS IS THE THIRTIETH OF THIRTY (30) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7063 | MAXCEM ELITE | CEMENT, DENTAL | EMA | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |