MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-01-28 for INSIGNIA 3787674*1*1 manufactured by Ormco Corportation.
[5321102]
A doctor alleged that tooth #11 and tooth #23 felt like they were out of the cortical bone after placement of insignia for a patient.
Patient Sequence No: 1, Text Type: D, B5
[12781497]
Information with regard to patient age and weight was not provided. Multiple attempts were made to the doctor's office on (b)(6) 2015 to obtain further information; however, the doctor's office has remained unresponsive. The product was not returned; therefore, no evaluations can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[36551670]
.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2016150-2015-00003 |
MDR Report Key | 4460816 |
Report Source | * |
Date Received | 2015-01-28 |
Date of Report | 2015-01-06 |
Date Mfgr Received | 2015-01-12 |
Date Added to Maude | 2015-01-28 |
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 | MS. KERRI CASINO |
Manufacturer Street | 1717 W COLLINS AVE |
Manufacturer City | ORANGE CA 92867 |
Manufacturer Country | US |
Manufacturer Postal | 92867 |
Manufacturer Phone | 7145167634 |
Manufacturer G1 | ORMCO CORPORATION |
Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
Manufacturer City | GLENDORA CA 91740 |
Manufacturer Country | US |
Manufacturer Postal Code | 91740 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INSIGNIA |
Generic Name | ORTHODONTIC PLASTIC BRACKET |
Product Code | DYW |
Date Received | 2015-01-28 |
Catalog Number | 3787674*1*1 |
Lot Number | 53675 |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ORMCO CORPORTATION |
Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-01-28 |