MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-13 for DAMON CLEAR DEBONDING INSTRUMENT manufactured by Ormco Corporation.
[14967718]
On july 13, 2010, a doctor reported to ormco corporation that while using the damon clear debonding instrument to remove an upper lateral bracket, the entire crown was removed.
Patient Sequence No: 1, Text Type: D, B5
[15167653]
The doctor reported that while using the damon clear debonding instrument to remove an upper lateral bracket, the entire crown was removed. As a result, a root canal had to be performed and a new crown had to be placed. No part number or lot number were provided. The instrument was returned to ormco. Investigation results are pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2010-00131 |
| MDR Report Key | 1799854 |
| Report Source | 05 |
| Date Received | 2010-08-13 |
| Date of Report | 2010-07-13 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2010-07-13 |
| Date Added to Maude | 2010-08-16 |
| 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 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA 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 CLEAR DEBONDING INSTRUMENT |
| Generic Name | ORTHODONTIC PLIER |
| Product Code | JEX |
| Date Received | 2010-08-13 |
| Device Availability | Y |
| 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 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2010-08-13 |