MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-17 for NITANIUM PALATAL EXPANDER 101-765 manufactured by Ortho Organizers.
[15446538]
A general dentist returned a broken nitanium palatal expander complaining that it has broken in a pt's mouth. During the investigation, doctor informed mfr that approximately 5 weeks after the placement, the pt felt that the expander was feeling "different" in her mouth and it's position has changed. The next day, when dentist examined the pt, he found that a wire segment (approximately 1 long x. 036" diameter) has broken off the expander. All the pieces of the nitanium palatal expander including the broken wire were removed from the pt's mouth. No medical intervention was needed and the incidence had no consequence or impact on the pt's health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2005-00004 |
| MDR Report Key | 718612 |
| Report Source | 05 |
| Date Received | 2005-08-17 |
| Date of Report | 2005-08-16 |
| Date of Event | 2005-07-20 |
| Date Mfgr Received | 2005-07-20 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2006-05-26 |
| 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 | 0 |
| Manufacturer Contact | CHHATTAR KUCHERIA, PH.D |
| Manufacturer Street | 1619 S. RANCHO SANTA FE ROAD |
| Manufacturer City | SAN MARCOS CA 92078 |
| Manufacturer Country | US |
| Manufacturer Postal | 92078 |
| Manufacturer Phone | 7604710206 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITANIUM PALATAL EXPANDER |
| Generic Name | ORTHODONTIC INTRAORAL APPLIANCE |
| Product Code | DYJ |
| Date Received | 2005-08-17 |
| Returned To Mfg | 2005-07-20 |
| Model Number | 101-765 |
| Catalog Number | 101-765 |
| Lot Number | 554206A05 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 707680 |
| Manufacturer | ORTHO ORGANIZERS |
| Manufacturer Address | 1619 SOUTH RANCHO SANTA FE RD. SAN MARCOS CA 92078 US |
| Baseline Brand Name | NITANIUM PALATAL EXPANDER |
| Baseline Generic Name | ORTHODONTIC INTRAORAL APPLIANCE |
| Baseline Model No | 101-765 |
| Baseline Catalog No | 101-765 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-17 |