FDA Adverse Event
Injury
Summary report: N
MAXCEM ELITE
MDR report key: 4102135
·
Received September 19, 2014
Report
- Report Number
- 2024312-2014-00621
- Event Type
- Injury
- Date Received
- September 19, 2014
- Report Date
- August 26, 2014
- Manufacturer
- KERR CORPORATION
- Product Code
- MZW
- PMA / PMN Number
- K073209
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
SPECIFIC INFORMATION WITH REGARD TO THE PATIENT'S GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. THE PATIENT RETRIEVED THE CROWN AND RETURNED TO THE OFFICE. THE DOCTOR CLEANED OUT AND RE-CEMENTED THE CROWN USING A DIFFERENT PRODUCT. TO DATE, THE PATIENT IS DOING FINE. A PHYSICAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.
Description of Event or Problem · 1
A DOCTOR'S OFFICE ALLEGED THAT SIX (6) PATIENTS HAD EXPERIENCED THE DEBONDING OF A CROWN APPROXIMATELY ONE (1) TO TWO (2) WEEKS AFTER PLACEMENT WITH THE MAXCEM ELITE BULK PRODUCT. THIS IS THE SIXTH OF SIX (6) COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584964 | MAXCEM ELITE | DENTAL CEMENT | MZW | KERR CORPORATION | 5121925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |