MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2005-11-04 for K-FLEXOREAMER A011C02501500 manufactured by Dentsply Detrey-dedent.
[17768832]
It was reported that a file separated in the canal during a procedure. As a result, the tooth was extracted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2005-00459 |
| MDR Report Key | 644809 |
| Report Source | 01,05,07 |
| Date Received | 2005-11-04 |
| Date of Report | 2005-10-05 |
| Date Mfgr Received | 2005-10-05 |
| Device Manufacturer Date | 1993-08-01 |
| Date Added to Maude | 2005-11-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST. STE. 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY MAILLEFER |
| Manufacturer Street | * |
| Manufacturer City | BALLAIGUES CH-1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-FLEXOREAMER |
| Generic Name | DENTAL HAND INSTRUMENT |
| Product Code | DZP |
| Date Received | 2005-11-04 |
| Returned To Mfg | 2005-10-05 |
| Model Number | NA |
| Catalog Number | A011C02501500 |
| Lot Number | 3224B |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 634297 |
| Manufacturer | DENTSPLY DETREY-DEDENT |
| Manufacturer Address | * KONSTANZ GM |
| Baseline Brand Name | X-FLEXOREANER |
| Baseline Generic Name | DENTAL HAND INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | A011C02501500 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-04 |