MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-01-06 for K-REAMER V010058025045 manufactured by Dentsply Vdw Gmbh.
[64130987]
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. Only unused product was returned for evaluation. The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
[64130988]
In this case a customer reported that a k-reamer "handle gets loose from the shaft. " treatment was completed. The dentist was not willing to provide more information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2016-00070 |
| MDR Report Key | 6230845 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-01-06 |
| Date of Report | 2017-01-06 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2017-01-06 |
| 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 | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY VDW GMBH |
| Manufacturer Street | BAYERWALDSTRASSE 15 |
| Manufacturer City | MUNICH, 81737 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-REAMER |
| Generic Name | REAMER, PULP CANAL, ENDODONTIC |
| Product Code | EKP |
| Date Received | 2017-01-06 |
| Returned To Mfg | 2016-12-08 |
| Model Number | NA |
| Catalog Number | V010058025045 |
| Lot Number | 1012001721 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | BAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |