MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-15 for DAMON UTILITY OPENING/ CLOSING PLIER 866-4006 manufactured by Ormco Corp..
[520105]
In 2006, a doctor informed ormco corporation that a damon opening/closing plier had a broken tip insert, braze failure.
Patient Sequence No: 1, Text Type: D, B5
[7798474]
There were no reported injuries associated with this incident. However, due to the prior submission of a reportable incident on the damon plier in 2005 (mdr #2016150-2005-00001: malfunction which led to a serious injury), this incident is reportable. This incident falls under the fda presumption that 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 | 2016150-2006-00046 |
| MDR Report Key | 773573 |
| Report Source | 05 |
| Date Received | 2006-08-15 |
| Date of Report | 2006-07-21 |
| Date of Event | 2006-07-01 |
| Date Mfgr Received | 2006-07-21 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2006-10-27 |
| 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 | WENDY URTEL |
| Manufacturer Street | 100 BAYVIEW CIRCLE SUITE 6000 |
| Manufacturer City | NEWPORT BEACH CA 92660 |
| Manufacturer Country | US |
| Manufacturer Postal | 92660 |
| Manufacturer Phone | 9492558767 |
| 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 UTILITY OPENING/ CLOSING PLIER |
| Generic Name | PLIER, ORTHODONTIC |
| Product Code | JEX |
| Date Received | 2006-08-15 |
| Returned To Mfg | 2006-07-21 |
| Model Number | NA |
| Catalog Number | 866-4006 |
| Lot Number | 04D36 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 761357 |
| Manufacturer | ORMCO CORP. |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US |
| Baseline Brand Name | DAMON UTILITY OPENING/CLOSING PLIER |
| Baseline Generic Name | ORTHODONTIC PLIER |
| Baseline Model No | NA |
| Baseline Catalog No | 866-4006 |
| Baseline ID | NA |
| Baseline Device Family | PLIER, ORTHODONTIC |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-15 |