MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-03 for MAXCEM ELITE 33872 manufactured by Kerr Corporation.
[4861126]
A doctor alleged that approximately five (5) patients had experienced the debonding of a crown after placement with the maxcem elite clear product. This is the second of five (5) complaints.
Patient Sequence No: 1, Text Type: D, B5
[11917906]
Specific information with regard to the patient's gender, age, and weight was not provided. The patient returned to the office and the doctor cleaned out and re-cemented the restoration using maxcem elite, without further incident. To date, the patient is doing fine. The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted. The doctor reported that he did not use the automix tips provided in the maxcem elite packaging as stated in the directions for use. He was aware that a new tip is intended to be used for each patient; however, in an attempt to save on "wasted product", he had extruded the material onto a mixing pad directly from the uncapped syringe and mixed the product by hand. It has been concluded that the intentional failure to follow instructions was the root cause of this incident. The doctor was informed by kerr on proper product usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00597 |
| MDR Report Key | 4055184 |
| Report Source | 05 |
| Date Received | 2014-09-03 |
| Date of Report | 2014-08-19 |
| Date Mfgr Received | 2014-08-19 |
| Date Added to Maude | 2014-09-03 |
| 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 | 2014-09-03 |
| Catalog Number | 33872 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-09-03 |