MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-06-04 for DAMON DEBONDING PLIERS 866-4008 manufactured by Ormco Corporation.
[1100008]
In 2009, ormco corporation received notification that during the debonding of brackets, the tip of the damon debonding plier broke and fractured the crown portion of a patient's tooth #41.
Patient Sequence No: 1, Text Type: D, B5
[8377862]
The doctor reported that the patient was sent to his dentist immediately after the incident to have the fractured tooth examined. The patient's dentist removed the fractured tooth portion, performed a root canal and placed a temporary crown. The patient is currently doing well and waiting for the placement of a permanent crown. The doctor reported that an evaluation of the patient's x-rays indicated that there was no damage to the patient's tooth structure prior to orthodontic treatment. The doctor has made several attempts to obtain additional patient dental history information from the patient's dentist; however, the patient's dentist has remained unresponsive. The product was returned to ormco corporation for evaluation. The evaluation was unable to determine the cause of the tip breakage. The results of material hardness testing indicated that the tip was within product specification. Visual examination of the returned product revealed rust on the tip and two pits which indicate where the fracture originated. It cannot be optically determined however, if these pits existed prior to the breakage or if they occurred as a result of the breakage. This is the final report. - attachment: [damondebondingplier 2016150-2009-00036 - evaluation. Pdf]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2009-00036 |
| MDR Report Key | 1398205 |
| Report Source | 01,05 |
| Date Received | 2009-06-04 |
| Date of Report | 2009-05-06 |
| Date of Event | 2009-05-06 |
| Date Mfgr Received | 2009-05-06 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2009-06-05 |
| 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 DEBONDING PLIERS |
| Generic Name | ORTHODONTIC PLIER |
| Product Code | JEX |
| Date Received | 2009-06-04 |
| Returned To Mfg | 2009-05-18 |
| Catalog Number | 866-4008 |
| Lot Number | 07F51F |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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; 2. Required No Informationntervention | 2009-06-04 |