MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-03-01 for ARCH BENDING PLIER * 803-0403 manufactured by Ormco Corp..
[21470112]
The doctor re-attached the chipped portions to the patient's teeth using a dental adhesive. The suspect device was over 10 years old - which is 5 years beyond the stated use-life of the product.
Patient Sequence No: 1, Text Type: N, H10
[21585893]
In january 2007 an attorney informed ormco corporation that an arch bending plier broke during an orthodontic adjustment performed by his client/doctor, causing the doctor to chip two of the patient's teeth (#'s 9 & 10).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2007-00008 |
| MDR Report Key | 822758 |
| Report Source | 04 |
| Date Received | 2007-03-01 |
| Date of Report | 2007-01-31 |
| Date of Event | 2006-11-01 |
| Date Mfgr Received | 2007-01-31 |
| Date Added to Maude | 2007-03-06 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WENDY URTEL |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167602 |
| 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 | ARCH BENDING PLIER |
| Generic Name | ORTHODONTIC PLIER |
| Product Code | JEX |
| Date Received | 2007-03-01 |
| Returned To Mfg | 2007-02-09 |
| Model Number | * |
| Catalog Number | 803-0403 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 810164 |
| Manufacturer | ORMCO CORP. |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US |
| Baseline Brand Name | ARCH BENDING PLIER |
| Baseline Generic Name | ORTHODONTIC PLIER |
| Baseline Model No | * |
| Baseline Catalog No | 803-0403 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2007-03-01 |