FDA Adverse Event
Injury
Summary report: N
MAXCEM ELITE
MDR report key: 2021105
·
Received March 16, 2011
Report
- Report Number
- 2024312-2011-00048
- Event Type
- Injury
- Date Received
- March 16, 2011
- Report Date
- February 16, 2011
- Manufacturer
- KERR CORPORATION
- Product Code
- EMA
- PMA / PMN Number
- K073209
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR COULD NOT IDENTIFY THE PRODUCT LOT NUMBER THAT WAS USED; THEREFORE NO FURTHER INVESTIGATION CAN TAKE PLACE AND THE EXACT CAUSE FOR THE DEBOND REMAINS INCONCLUSIVE. THE DOCTOR STATED THAT THE PATIENT IS DOING FINE AND THAT THE CROWN WAS RE-CEMENTED WITH MAXCEM ELITE WITHOUT FURTHER INCIDENT.
Description of Event or Problem · 1
ON (B)(6), 2011 A DOCTOR REPORTED APPROXIMATELY TWENTY (20) CASES IN WHICH RESTORATIONS THAT HAD BEEN PLACED WITH MAXCEM ELITE DEBONDED. THE DOCTOR WAS UNABLE TO PROVIDE DETAILS ON THE INCIDENTS. THIS MDR IS THE SIXTEENTH OF TWENTY 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| R |