MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-11 for ENDO ACCESS - X GATES XGATE manufactured by Tulsa Dental Products Llc.
[123506293]
There has been a previous report received for a similar device 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. The device was not returned for evaluation and the lot number that was provided is invalid.
Patient Sequence No: 1, Text Type: N, H10
[123506294]
It was reported that an endo access x gates drill broke during use; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2018-00153 |
| MDR Report Key | 7958159 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-11 |
| Date Added to Maude | 2018-10-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 MAILLEFER |
| Manufacturer Street | CHEMIN DU VERGER 3 |
| Manufacturer City | BALLAIGUES, 1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO ACCESS - X GATES |
| Generic Name | DRILL, DENTAL, INTRAORAL |
| Product Code | DZA |
| Date Received | 2018-10-11 |
| Model Number | NA |
| Catalog Number | XGATE |
| Lot Number | 149022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-11 |