MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-27 for DAMON COPPER NITI WIRE 205-1902 manufactured by Ormco Corporation.
[18905381]
There are no reported injuries associated with this incident. However, due to the prior submission of a reportable incident on the damon copper niti wire in 2008 (mdr #2016150-2008-00001: malfunction which required intervention to prevent permanent impairment/damage)this incident is reportable. This incident falls under the fda presumption this type of malfunction is likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
[18963617]
In 2009, a doctor informed ormco corporation that he had three damon cuniti wire breakages in the same patient and believes the orthodontic wire breakages are caused by something the patient is eating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2009-00019 |
| MDR Report Key | 1351883 |
| Report Source | 05 |
| Date Received | 2009-03-27 |
| Date of Report | 2009-03-02 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2009-03-02 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2009-06-10 |
| 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 | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| 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 | DAMON COPPER NITI WIRE |
| Generic Name | WIRE, ORTHODONTIC |
| Product Code | DZC |
| Date Received | 2009-03-27 |
| Returned To Mfg | 2009-03-03 |
| Catalog Number | 205-1902 |
| Lot Number | 08G137G |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2009-03-27 |