MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-19 for FIBERKLEER POST manufactured by Pentron Clinical.
[4205559]
A doctor's office alleged that twenty (20) patient had experienced post failures after placement with fiberkleer post. This is the eleventh of twenty (20) reports.
Patient Sequence No: 1, Text Type: D, B5
[11544251]
Patient information with regard to gender, age and weight was not provided. Upon the patient's return visit, the doctor repeated the procedure, inserts metal posts and changed his bonding/cementation process. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00071 |
| MDR Report Key | 3634754 |
| Report Source | 05 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-01-30 |
| Date Mfgr Received | 2014-01-30 |
| Date Added to Maude | 2014-02-19 |
| 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 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 | FIBERKLEER POST |
| Generic Name | ROOT CANAL POST |
| Product Code | ELR |
| Date Received | 2014-02-19 |
| 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 | 2014-02-19 |