MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for SURESMILE ALIGNER 856379007023 manufactured by Orametrix Inc..
[179231861]
Because this event resulted in the need for medical intervention, it is reportable per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[179231862]
A doctor stated that while a patient was wearing suresmile aligners from staged models 1, she wasn't able to finish the lower due to the aligners "bunching up" on the lingual side of the anterior teeth. They did a refinement and had the same problem with staged models 2, around aligner #10 on the lower. Patient and doctor stated that they did all the proper ipr as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649995-2020-00001 |
| MDR Report Key | 9703901 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 8494424 |
| Manufacturer G1 | ORAMETRIX INC. |
| Manufacturer Street | 2350 CAMPBELL CREEK BLVD. SUITE 400 |
| Manufacturer City | RICHARDSON, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESMILE ALIGNER |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-02-12 |
| Model Number | NA |
| Catalog Number | 856379007023 |
| Lot Number | L2A6 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORAMETRIX INC. |
| Manufacturer Address | 2350 CAMPBELL CREEK BLVD. SUITE 400 RICHARDSON, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |