MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-10 for ORTHO SOLO 740-0269 manufactured by Ormco Corp..
[42099476]
In a f/u conversation with the orthodontist, the use of ortho solo could not be confirmed in any of the 6 instances. Initially, the orthodontist thought ortho solo was used, but since no records were retained to confirm that fact, the orthodontist was not 100% sure ortho solo was involved. The orthodontist did not provide any lot numbers of products allegedly involved nor did he return any suspected products for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[42099477]
Between (b)(6) 2004, six instances (6 different patients) occurred in which the use of ortho solo, a sealant and bond enhancer, allegedly attributed to enamel fractures while debonding orthodontic brackets. All of the patients were referred to their general dentists to assess their conditions. Three of six patients required composite restorations to repair the enamel fractures. This is the third of three mdr's regarding the alleged association between ortho solo and the enamel fractures that occurred between (b)(6) 2004.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2004-00004 |
| MDR Report Key | 5547801 |
| Date Received | 2004-08-10 |
| Date of Report | 2004-07-20 |
| Date of Event | 2004-01-01 |
| Date Mfgr Received | 2004-07-20 |
| Date Added to Maude | 2016-04-05 |
| 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 | WENDY URTEL |
| Manufacturer Street | 1717 WEST COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167425 |
| Manufacturer G1 | ORMCO CORP. |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| 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 | 0 |
| Brand Name | ORTHO SOLO |
| Generic Name | SEALER AND BOND ENHANCER |
| Product Code | EBC |
| Date Received | 2004-08-10 |
| Model Number | NA |
| Catalog Number | 740-0269 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORP. |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-10 |