MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-24 for QUICK-FIT MOLAR BAND ASSEMBLIES SPECIFIC UNKNOWN manufactured by Ortho Technology, Inc.
[20796698]
A doctor's office reported they have had an issue with welds failing in orthodontic stainless steel bands and this ultimately caused an issue requiring medical intervention in 2 patients. The first patient, a (b)(6) female, was wearing a forces appliance, that was placed in the mouth utilizing our orthodontic quick-fit molar band assemblies. The buccal tube broke away from the band. This occurred in the middle of the night and by the time the patient reached the orthodontist's office the buccal mucosa was cut and completely irritated. She had swelling on her cheek. The doctor administered a mixture of benzocaine and antibiotics to facilitate healing and prescribed oral antibiotics as well. A second patient, a (b)(6) male utilizing the same type of forces appliance had a very similar problem and the doctor treated the exact same.
Patient Sequence No: 1, Text Type: D, B5
[20911116]
We are the legal manufacturer of the quick-fit band assemblies and obtain them from a manufacturer in (b)(4). The bands that failed were not returned for evaluation, however the customer sent back the remaining bands from their stock and we tested them at our facility. We also sent a sampling of the returned bands to the manufacturer for testing as well. The manufacturer concluded there is an issue in their manufacturing process and qc processes that did not detect the issue in our customer's returned product. All of our inventory was quarantined as soon as this information was determined and it has all been sent back to the manufacturer's counterpart in the us for evaluation, repair or replacement. At this time they are ensuring their proposed corrective action is effective before returning any product to us. In the meantime, we are backordering quick-fit orders and/or suggesting a substitute.
Patient Sequence No: 1, Text Type: N, H10
[20780181]
A doctor's office reported they have had an issue with welds failing in orthodontic stainless steel bands and this ultimately caused an issue requiring medical intervention in 2 patients. The first patient, a (b)(6) female, was wearing a forces appliance, that was placed in the mouth utilizing our orthodontic quick-fit molar band assemblies. The buccal tube broke away from the band. This occurred in the middle of the night and by the time the patient reached the orthodontist's office the buccal mucosa was cut and completely irritated. She had swelling on her cheek. The doctor administered a mixture of benzocaine and antibiotics to facilitate healing and prescribed oral antibiotics as well. A second patient, a (b)(6) male utilizing the same type of forces appliance had a very similar problem and the doctor treated the exact same.
Patient Sequence No: 2, Text Type: D, B5
[20895736]
We are the legal manufacturer of the quick-fit band assemblies and obtain them from a manufacturer in brazil. The bands that failed were not returned for evaluation, however, the customer sent back the remaining bands from their stock and we tested them at our facility. We also sent a sampling of the returned bands to the manufacturer for testing as well. The manufacturer concluded there is an issue in their manufacturing process and qc processes that did not detect the issue in our customer's returned product. All of our inventory was quarantined as soon as this information was determined and it has all been sent back to the manufacturer's counterpart in the us for evaluation, repair or replacement. At this time they are ensuring their proposed corrective action is effective before returning any product to us. In the meantime, we are backordering quick-fit orders and/or suggesting a substitute.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 1056191-2012-00001 |
| MDR Report Key | 2593894 |
| Report Source | 05,06 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-24 |
| Date of Event | 2012-04-26 |
| Date Mfgr Received | 2012-04-27 |
| Date Added to Maude | 2012-08-03 |
| 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 | QUICK-FIT MOLAR BAND ASSEMBLIES |
| Generic Name | ECM - ORTHODONTIC BAND/TUBE |
| Product Code | ECM |
| Date Received | 2012-05-24 |
| Model Number | QUICK-FIT |
| Catalog Number | SPECIFIC UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 2012-05-24 |
| 2 | 0 | 2012-05-24 |