FDA Adverse Event
Injury
Summary report: N
MAXCEM ELITE
MDR report key: 1831562
·
Received September 10, 2010
Report
- Report Number
- 2024312-2010-00086
- Event Type
- Injury
- Date Received
- September 10, 2010
- Report Date
- August 12, 2010
- Manufacturer
- KERR CORPORATION
- Product Code
- EMA
- PMA / PMN Number
- K073209
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
A DOCTOR REPORTED THAT A CROWN THAT HAD BEEN CEMENTED WITH MAXCEM ELITE HAD DEBONDED. NEITHER AN EVALUATION NOR A REVIEW OF THE MANUFACTURING RECORDS COULD BE CONDUCTED, AS THE PRODUCT WAS NOT RETURNED FROM THE DOCTOR, NOR DID THE DOCTOR PROVIDE THE LOT NUMBER(S) USED. BECAUSE NO FURTHER INVESTIGATION IS POSSIBLE, THE CAUSE FOR THE DEBOND REMAINS INCONCLUSIVE.
Description of Event or Problem · 1
ON (B)(6), 2010, A DOCTOR REPORTED THAT A CROWN THAT HAD BEEN PLACED WITH MAXCEM ELITE CEMENT DE-BONDED. THIS IS THE SECOND OF FOUR REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXCEM ELITE | DENTAL CEMENT | EMA | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |