MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-28 for FIBREKOR POST manufactured by Pentron Clinical.
[4413856]
A doctor's office alleged that seven (7) patients had experienced the debonding of a fibrekor fiber post with the core and crown still attached. This is the fourth of seven (7) reports.
Patient Sequence No: 1, Text Type: D, B5
[12013068]
Patient information with regard to gender, age, and weight was not provided. A new post and core was created for the patient. The doctor retrofitted the new post and core to the original crown and cemented it; however, the new post and core debonded with the original crown attached a second time. During the second debonding, the patient had experienced the loss of tooth structure. The doctor performed a root extraction procedure for the patient, and the patient will return to the office for an evaluation for a possible implant procedure. At this time, the patient is doing fine. An update will be provided for this patient if any new information is received. The product involved in the alleged incident was not returned and no lot number or catalog number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00422 |
| MDR Report Key | 3836856 |
| Report Source | 05 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-01 |
| Date Mfgr Received | 2014-05-01 |
| Date Added to Maude | 2014-05-29 |
| 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 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | PENTRON CLINICAL |
| 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 | FIBREKOR POST |
| Generic Name | ROOT CANAL POST |
| Product Code | ELR |
| Date Received | 2014-05-28 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTRON CLINICAL |
| Manufacturer Address | 1717 WEST COLLINS AVENUE ORANGE 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-05-28 |