MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-22 for GRENGLOO 740-0320 manufactured by Ormco Corporation.
[1602678]
On (b) (6) 2010, a doctor reported that two patients experienced enamel removal when the doctor debonded a damon 3mx bracket that had been placed using grengloo with ortho solo. This is the first of two incidents.
Patient Sequence No: 1, Text Type: D, B5
[8725314]
The doctor stated that he repaired the damaged enamel with composite and the patient is doing fine. The grengloo kit was not returned for testing, and no lot number was provided, therefore a review of the manufacturing records could not be conducted. One of the damon 3mx brackets was returned to ormco for evaluation and observed under 30x magnification. It was noted that none of the adhesive came off of the bracket pad. In addition, during a conference call with the doctor on (b) (6) 2010, the doctor stated that he was bonding the brackets toward the gingiva which is the weaker part of the tooth's enamel and is more susceptible to damage. The doctor also stated that he debonded the brackets without first loosening the adhesive. Going forward, the doctor stated that he will bond the brackets more occlusally and he will start the debonding process by grinding away part of the pad first. The doctor's statements have led to the conclusion that the enamel damage was caused by user error (i. E. Bracket placement and method of debonding) and not by the product itself.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2010-00101 |
| MDR Report Key | 1767477 |
| Report Source | 05 |
| Date Received | 2010-07-22 |
| Date of Report | 2010-06-23 |
| Date Mfgr Received | 2010-06-23 |
| Date Added to Maude | 2010-07-22 |
| 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 | GRENGLOO |
| Generic Name | BRACKET ADHESIVE |
| Product Code | DYH |
| Date Received | 2010-07-22 |
| Catalog Number | 740-0320 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-07-22 |