MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-05 for NITANIUM PALATAL EXPANDER 101-768 manufactured by Ortho Organizers, Inc..
[756351]
In 2007, ortho organizers received a complaint report from dr. Doctor installed a 101-768 size 40 nitanium palatal expander in his patient in 2006. His patient reported that when she woke on the morning of approx two months later, the left arm (wire) of the device had broken off and was missing. The doctor could not confirm the patinet's report and noted that the patient disliked the device and complained about discomfort from initial installation. It is possible that the patient ingested (swallowed) the missing wire section, although there is no conclusive evidence she did. The doctor removed the remaining portion of the broken device at that time, but did not install a new device due to the patient's complaint about discomfort. The doctor reported the malfunction on march 7th. He further reports that there was no medical intervention and there has been no injury or symptoms of any adverse impact on the patient's health in the 3 months since the malfunction occurred.
Patient Sequence No: 1, Text Type: D, B5
[7931927]
The device in question was analyzed and evidence of brittle fracture was confirmed. Extensive engineering analysis of similar malfunctions in the same time frame that this device manufactured conclusively determined that the most probable cause of the device malfunction is likely due to a decrease in the ductility and elongation properties of the ortholoy arm as-received from the vendor. When the wire is too hard, brittle fracture can occur. Excessive practitioner manipulation (bending) to fit the patient can further increase fracture probability. This device was produced in august 2005, installed in 2006, and failed about 2 months later. Corrective action: to increase ductility of the wire and prevent brittle fracture of devices delivered to customers, the following actions have been implemented by ortho organizers, inc. Two proof-testing steps have been added to the manufacturing process to identify and screen any potentially brittle appliances prior to shipment. The ortholoy wire arms are annealed at ortho organizers prior to assembly to ensure sufficient ductility and elongation properties. Tensile strength and elongation specifications have been revised for the supplied ortholoy wire arms. These devices have been marketed for over 10 years. The failure rate associated with the ortholoy arm is an event with a low occurrence rate (less than 0. 02%).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2081322-2007-00001 |
| MDR Report Key | 961747 |
| Report Source | 05 |
| Date Received | 2007-04-05 |
| Date of Report | 2007-04-04 |
| Date of Event | 2006-12-27 |
| Date Mfgr Received | 2007-03-08 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2007-12-12 |
| 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 | DAVID MCGRATH |
| Manufacturer Street | 1822 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604488730 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| 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 | 2007-04-05 |
| Returned To Mfg | 2007-04-03 |
| Model Number | 101-768 |
| Catalog Number | 101-768 |
| Lot Number | 560212C05 |
| 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 | 931787 |
| Manufacturer | ORTHO ORGANIZERS, INC. |
| Manufacturer Address | * CARLSBAD CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-05 |