MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2015-06-18 for NI-TI WIRE manufactured by Ormco Corporation.
[21120369]
A doctor alleged that the niti archwire had broken in a patient's mouth and the patient had swallowed the broken part during daily activity.
Patient Sequence No: 1, Text Type: D, B5
[21443927]
Specific patient information with regard to gender, age and weight was not provided. Although the doctor identified two (2) different catalog numbers associated with the breakage of the wire, he could not verify which catalog number had broken; therefore, no lot numbers were identified. The catalog numbers involved in the alleged incident included catalog numbers 205-0004, 205-0008. The patient sought further medical attention at the emergency room. An x-ray was taken and surgery was performed to remove the broken part. It was reported that the doctor believes that the archwire had been broken through deliberate and careless action by the patient. No further patient health status information was reported. An update will be provided if any further information is obtained. The product involved in this incident was not returned and no lot number was provided; therefore, no further evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2015-00017 |
| MDR Report Key | 4853075 |
| Report Source | 07,08 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-05-28 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2015-06-18 |
| 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 | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 S. LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9099625730 |
| 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 | NI-TI WIRE |
| Generic Name | WIRE, ORTHODONTIC |
| Product Code | ECN |
| Date Received | 2015-06-18 |
| Operator | DENTIST |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2015-06-18 |