MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-22 for PURE SAPPHIRE BRACKETS PURE BRAND SPECIFIC UNK manufactured by Ortho Technology, Inc..
[1276613]
A doctor's office reported an issue with de-bonding aesthetic brackets. During de-bonding, the doctor used a de-bonding plier secured the bracket distal/mesial and slowly squeezed the instrument, the bracket fractured and came away from the tooth, with the adhesive in place and tooth enamel attached. This occurred on the upper left 5 (2nd bicuspid). The doctor referred the pt to a general dentist to have the enamel repaired, which makes this a reportable event. After discussion with the doctor, it was determined the doctor did not use a burr to remove the flash. Doctor stated that the adhesive he used is pink when applied and he removes all flash during the bonding process. However, our instructions read you must remove all adhesive around the bracket "flash" prior to de-bonding.
Patient Sequence No: 1, Text Type: D, B5
[8495348]
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. We are improving instructions by bolding "do not twist or pull the bracket" and ensuring the instructions are available online and prominently evident with each order.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056191-2010-00001 |
| MDR Report Key | 1586163 |
| Report Source | 05,06 |
| Date Received | 2010-01-22 |
| Date of Report | 2010-01-22 |
| Date of Event | 2009-12-22 |
| Date Mfgr Received | 2009-12-23 |
| Date Added to Maude | 2011-04-28 |
| 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 | 2010-01-22 |
| Model Number | PURE BRAND |
| Catalog Number | SPECIFIC UNK |
| 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 | 2010-01-22 |