MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-02 for PROTAPER U ROTARY F2 21MM PTURF221 manufactured by Tulsa Dental Products Llc.
[140640103]
As a result of this malfunction, the potential for surgical intervention exists 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 21cfr part 803. The event outcome is unknown as of this mdr evaluation. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[140640104]
It was reported that a protaper finishing file broke during use. The patient has been referred to a specialist to have the broken part removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2019-00049 |
| MDR Report Key | 8473414 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-23 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2018-02-27 |
| Date Added to Maude | 2019-04-02 |
| 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 | TULSA DENTAL PRODUCTS LLC |
| Manufacturer Street | 608 ROLLING HILLS DRIVE |
| Manufacturer City | JOHNSON CITY TN 37604 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTAPER U ROTARY F2 21MM |
| Generic Name | DRILL, DENTAL, INTRAORAL |
| Product Code | DZA |
| Date Received | 2019-04-02 |
| Returned To Mfg | 2019-03-20 |
| Catalog Number | PTURF221 |
| Lot Number | 1477152 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TULSA DENTAL PRODUCTS LLC |
| Manufacturer Address | 608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-02 |