FDA Adverse Event
Injury
Summary report: N
MAXCEM ELITE
MDR report key: 2021074
·
Received March 16, 2011
Report
- Report Number
- 2024312-2011-00034
- 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 NUMBERS THAT WERE USED FOR THE INITIAL PLACEMENT OF THE PATIENT'S CROWN AND FOR THE RE-CEMENTATION OF THE DE-BONDED CROWN; THEREFORE NO FURTHER INVESTIGATION CAN TAKE PLACE AND THE EXACT CAUSE FOR THE DEBONDS REMAINS INCONCLUSIVE. THE DOCTOR CONFIRMED THAT THE PATIENT IN THIS INCIDENT IS DOING FINE AND THE CROWN WILL BE RE-MADE.
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 COULD NOT PROVIDE DETAILS ON THE INCIDENTS. THIS MDR IS THE SECOND OF TWENTY REPORTS. IN THIS PARTICULAR INCIDENT, A PATIENT SWALLOWED A CROWN THAT DEBONDED AFTER IT HAD BEEN RE-CEMENTED WITH MAXCEM ELITE.
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 |