MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-02-15 for K-REAMER V040353025020 manufactured by Dentsply Vdw Gmbh.
[3322996]
Int this event it was reported that a k-reamer separated; the separated piece could not be retrieved and was incorporated into the fill.
Patient Sequence No: 1, Text Type: D, B5
[10643035]
As a result of this malfunction, the potential for surgical intervention exists (though inadvisable per expert opinion provided by dr. (b)(6)) to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files. This event; therefore, is reportable per 21 cfr part 803. The package of files was returned without the broken file. The returned files were evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611053-2013-00002 |
| MDR Report Key | 3040501 |
| Report Source | 01,05 |
| Date Received | 2013-02-15 |
| Date of Report | 2013-01-17 |
| Date Mfgr Received | 2013-01-17 |
| Date Added to Maude | 2013-04-29 |
| 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 | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| 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 |
| Product Code | EKP |
| Date Received | 2013-02-15 |
| Catalog Number | V040353025020 |
| Lot Number | 024423 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-15 |