MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-10 for BASE RX SGL 022/LL7 -30T -1A 4D 268-472-80 manufactured by Dentsply Sirona Orthodontics Inc..
[132595300]
Therefore, because intervention was required, this event is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[132595301]
A doctor claims that the new base rx skus have a lower profile and as a result they are seeing an unwanted eruption of the molars and this is prolonging treatment times for the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2418500-2018-00001 |
| MDR Report Key | 8233396 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-10 |
| Date of Report | 2019-04-18 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-01-10 |
| 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 SIRONA ORTHODONTICS INC. |
| Manufacturer Street | 7290 26TH COURT EAST |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASE RX SGL 022/LL7 -30T -1A 4D |
| Generic Name | TUBE, ORTHODONTIC |
| Product Code | DZD |
| Date Received | 2019-01-10 |
| Model Number | NA |
| Catalog Number | 268-472-80 |
| Lot Number | 00135290 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY SIRONA ORTHODONTICS INC. |
| Manufacturer Address | ONE CA PLAZA SUITE 100 ISLANDIA NY 11749 US 11749 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-10 |