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 2019-02-07 for K-REAMERS, CC+, STERILE V040353025030 manufactured by Dentsply Vdw Gmbh.
[135386808]
While no injury was reported, 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. Received used product upper part small pieces, therefore was an investigation from the small pieces not possible and lot number was also not available. No unused instruments available. Root causes are unknown for the breakage.
Patient Sequence No: 1, Text Type: N, H10
[135386809]
In this event it was reported that a k-reamer broke during use. The separated piece could not be retrieved and remained in the canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2019-00003 |
| MDR Report Key | 8315721 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2019-02-07 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| 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-REAMERS, CC+, STERILE |
| Generic Name | REAMER, PULP CANAL, ENDODONTIC |
| Product Code | EKP |
| Date Received | 2019-02-07 |
| Returned To Mfg | 2019-01-15 |
| Model Number | NA |
| Catalog Number | V040353025030 |
| Lot Number | UNK |
| 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 | 2019-02-07 |