MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-13 for DAMON COPPER NITI WIRE 205-1902 manufactured by Ormco Corporation.
[1305939]
On october 24, 2009, a doctor informed ormco corporation that he had a damon cuniti wire breakage.
Patient Sequence No: 1, Text Type: D, B5
[8360598]
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 on february 6, 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
| Report Number | 2016150-2009-00107 |
| MDR Report Key | 1526411 |
| Report Source | 05 |
| Date Received | 2009-11-13 |
| Date of Report | 2009-10-28 |
| Date Mfgr Received | 2009-10-24 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2010-03-17 |
| 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 | 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 | 2009-11-13 |
| Returned To Mfg | 2009-10-24 |
| Catalog Number | 205-1902 |
| Lot Number | 030912101 |
| 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 | 2009-11-13 |