MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-05 for ADVAN SYNC 600-4000 manufactured by Ormco Corporation.
[2119003]
On (b)(6) 2011, a customer informed ormco corporation that a mesio-buccal cusp had fractured when removing an advancsync appliance.
Patient Sequence No: 1, Text Type: D, B5
[9279711]
On (b)(6) 2011, a customer informed ormco corporation that when removing the advancsync appliance from tooth (#3 upper-right, 1st molar), the mesio-buccal cusp fractured. Patient went to dentist for restoration of the tooth and is doing fine. No information regarding lot number was received. No evaluation could be conducted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2011-00139 |
| MDR Report Key | 2149739 |
| Report Source | 05 |
| Date Received | 2011-07-05 |
| Date of Report | 2011-06-08 |
| Date of Event | 2011-06-08 |
| Date Mfgr Received | 2011-06-09 |
| Date Added to Maude | 2011-07-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| 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 | ADVAN SYNC |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | DYJ |
| Date Received | 2011-07-05 |
| Catalog Number | 600-4000 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| 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 | 2011-07-05 |