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 V010058021045 manufactured by Dentsply Vdw Gmbh.
[64119256]
Since this event resulted in permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur. As such, this event meets the definition of a reportable event per 21 cfr 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
[64119257]
In this case a customer reported that a k-reamer "handle gets loose from the shaft. " a patient's tooth was extracted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2016-00068 |
| MDR Report Key | 6230835 |
| 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 | V010058021045 |
| Lot Number | 118889 |
| 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 | 1. Deathisabilit | 2017-01-06 |