MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-13 for PURE SAPPHIRE BRACKETS S22931 manufactured by Ortho Technology, Inc..
[1168332]
A doctor's office reported an issue with de-bonding aesthetic brackets. The reporter stated this was the first time the doctor had re-bonded this brand of brackets, so he had the instructions out for reference. Upon de-bonding, the doctor realized the adhesive remained on the bracket and also fractured a portion of the pt's enamel on a lower bicuspid. As standard practice, the doctor removes all flash before curing the adhesive, therefore, there was no visible adhesive to be removed before de-bonding (per our instructions). The reporter stated the doctor generally flexes from side to side, but had to flex vertically to get the bracket to come off in this instance. The doctor did not follow de-bonding directions, since they state do not twist or pull the bracket. In addition, the doctor claims to have used our angled de-bonding plier, however, we show no record of purchase of this plier or any other de-bonding pliers. The doctor is aware of the inherent issues with de-bonding aesthetic brackets, and makes all pts sign a waiver. Per the reporter, this particular pt already had restorative work scheduled and had this repair included by her general dentist. The bracket was not returned for eval or to determine if it was indeed our brand of bracket.
Patient Sequence No: 1, Text Type: D, B5
[8436249]
This brand of bracket has specific de-bonding instructions; "do not twist or pull the bracket. Remove all flash from around the brackets with a high speed de-bonding bur. Grasp the bracket with a straight or angled de-bonding plier at the bracket-adhesive interface. Gently squeeze the plier and gradually increase pressure until the bracket comes free from the tooth. " even though our investigation concludes operator error, the pt required intervention to repair, therefore, it is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056191-2009-00001 |
| MDR Report Key | 1414777 |
| Report Source | 05,06 |
| Date Received | 2009-07-13 |
| Date of Report | 2009-07-06 |
| Date of Event | 2009-05-12 |
| Date Mfgr Received | 2009-06-02 |
| Date Added to Maude | 2011-03-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI HUTCHINS |
| Manufacturer Street | 17401 COMMERCE PARK BLVD |
| Manufacturer City | TAMPA FL 33647 |
| Manufacturer Country | US |
| Manufacturer Postal | 33647 |
| Manufacturer Phone | 8139915896 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURE SAPPHIRE BRACKETS |
| Generic Name | NJM - CERAMIC ORTHODONTIC BRACKETS |
| Product Code | NJM |
| Date Received | 2009-07-13 |
| Model Number | S22931 |
| Catalog Number | S22931 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO TECHNOLOGY, INC. |
| Manufacturer Address | TAMPA FL 33647 US 33647 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-13 |