MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2006-08-02 for NITANIUM PALATAL EXPANDER 101-764 manufactured by Ortho Organizers, Inc..
[504827]
A 101-764 nitanium palatal expander was returned to ortho organizers from our foreign distributor with a notice that the device broke in the patient's mouth. All pieces of the device were present and accounted for in the returned package, verifying the patient did not ingest any portion of the broken device. No required medical intervention or adverse impact on the patient's health was reported.
Patient Sequence No: 1, Text Type: D, B5
[7795851]
Evaluation summary: visual examination of the failed nitanium palatal expander showed that the ortholoy arm (wire) has broken, where it comes out of the end insert. Failure analysis using a scanning electron microscope (sem) revealed multiple fracture origins due to lateral flexure of the ortholoy arm. Root cause analysis was performed by reviewing the (i) failure analysis data (ii) material physical properties and (iii) past performance history of the device. It was determined that the most probable failure cause was due to decrease in the elongation and ductility of the ortholoy arm as-received from the vendor. To remedy this situation, the following actions have been undertaken: two proof-testing steps have been added to the manufacturing process to eliminate potentially brittle appliances. Entire stock of ortholoy wires has been annealed to increase the elongation and ductility. Tensile strength and elongation specifications for the incoming ortholoy wire has been changed and the supplier has been notified. We have been marketing these appliances for over 10 years. The breakage rate of ortholoy arms is an event with a low rate of occurrence (less than 0. 02%).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2081322-2006-00001 |
| MDR Report Key | 760026 |
| Report Source | 01,08 |
| Date Received | 2006-08-02 |
| Date of Report | 2006-07-13 |
| Date of Event | 2006-06-23 |
| Date Mfgr Received | 2006-06-23 |
| Date Added to Maude | 2006-09-15 |
| 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 | 0 |
| Manufacturer Contact | DAVID MCGRATH |
| Manufacturer Street | 1822 ASTON AVE |
| Manufacturer City | CARLSBAD CA 92078 |
| Manufacturer Country | US |
| Manufacturer Postal | 92078 |
| Manufacturer Phone | 7604488730 |
| 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 DEVICE |
| Product Code | DYJ |
| Date Received | 2006-08-02 |
| Returned To Mfg | 2006-06-23 |
| Model Number | 101-764 |
| Catalog Number | 101-764 |
| Lot Number | * |
| 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 | 747946 |
| Manufacturer | ORTHO ORGANIZERS, INC. |
| Manufacturer Address | * CARLSBAD CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-02 |