MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-19 for MAXCEM ELITE 34418 manufactured by Kerr Corporation.
[20458161]
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 third of six (6) complaints.
Patient Sequence No: 1, Text Type: D, B5
[20501654]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00618 |
| MDR Report Key | 4102119 |
| Report Source | 05 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-08-26 |
| Date Mfgr Received | 2014-08-26 |
| Device Manufacturer Date | 2014-03-15 |
| Date Added to Maude | 2014-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92867 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXCEM ELITE |
| Generic Name | DENTAL CEMENT |
| Product Code | MZW |
| Date Received | 2014-09-19 |
| Catalog Number | 34418 |
| Lot Number | 5121925 |
| Device Expiration Date | 2015-08-01 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 WEST COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-09-19 |