MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-04 for PROTAPER GOLD ROTARY F1 21MM PTGRF121 manufactured by Tulsa Dental Products Llc.
[107344444]
As a result of this error, the files lack flexibility, which can lead to file separation. Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[107344445]
It was reported that a protaper gold file was not bending like usual. The doctor stated the files felt more like protaper universal files. However, upon investigation on april 6, 2018, it was found that the files were in fact protaper gold files, but they were not heat treated to specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2018-00035 |
| MDR Report Key | 7486766 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-04 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2018-01-06 |
| Date Added to Maude | 2018-05-04 |
| 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 | 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTAPER GOLD ROTARY F1 21MM |
| Generic Name | DRILL, DENTAL, INTRAORAL |
| Product Code | DZA |
| Date Received | 2018-05-04 |
| Returned To Mfg | 2018-03-16 |
| Model Number | NA |
| Catalog Number | PTGRF121 |
| Lot Number | 00173645 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-04 |