MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-16 for FLAT PLANE SPLINT manufactured by Allesee Orthodontic Appliances.
[54934570]
The doctor alleged that the patient's porcelain crown fractured.
Patient Sequence No: 1, Text Type: D, B5
[56012553]
Doctor alleged that a patient's crowns fractured due to the appliance. Several attempts were made to the office with no return call. An update will be provided upon receipt of new information.
Patient Sequence No: 1, Text Type: N, H10
[56012554]
The doctor alleged that the patient's porcelain crown fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184045-2016-00004 |
| MDR Report Key | 5956667 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-16 |
| Date of Report | 2016-07-26 |
| Date of Event | 2016-08-04 |
| Date Mfgr Received | 2016-07-26 |
| Device Manufacturer Date | 2016-05-24 |
| Date Added to Maude | 2016-09-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARI LAMBERT |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal | 53177 |
| Manufacturer Phone | 2623213670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLAT PLANE SPLINT |
| Generic Name | FLAT PLANE SPLINT |
| Product Code | KMY |
| Date Received | 2016-09-16 |
| Lot Number | 7990145 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-16 |