MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-05-01 for FIBER POST REMOVAL KIT X-80681P manufactured by Rtd.
[171580]
Pilot drill broke off in canal as dentist was inserting it. Drill broke off inside of the tooth and pt requested to have tooth extracted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420052-2000-00001 |
| MDR Report Key | 276130 |
| Report Source | 05 |
| Date Received | 2000-05-01 |
| Date of Report | 2000-05-01 |
| Date of Event | 2000-03-30 |
| Date Mfgr Received | 2000-04-24 |
| Date Added to Maude | 2000-05-05 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHY JOUNG, PH.D. |
| Manufacturer Street | 1100 W. IRVING PARK ROAD |
| Manufacturer City | SCHAUMBURG IL 60193 |
| Manufacturer Country | US |
| Manufacturer Postal | 60193 |
| Manufacturer Phone | 8475346106 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBER POST REMOVAL KIT |
| Generic Name | DRILL |
| Product Code | EJY |
| Date Received | 2000-05-01 |
| Model Number | NA |
| Catalog Number | X-80681P |
| Lot Number | SEE H10 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267268 |
| Manufacturer | RTD |
| Manufacturer Address | 3, RUE LOUIS NEEL TECHNOPARC ESPACE GAVANIERE ST. EQREVE FR 38120 |
| Baseline Brand Name | FIBER POST REMOVAL KIT |
| Baseline Generic Name | POST REMOVAL KIT |
| Baseline Model No | X-80681P |
| Baseline Catalog No | X-80681P |
| Baseline ID | NA |
| Baseline Device Family | POST REMOVAL DRILL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-05-01 |