MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-20 for APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET 4006-250 manufactured by 3m Unitek Corporation.
[58016015]
Doctor states that the tooth had no evidence of damage prior to the patient's initial bonding. The hygienist who performed the debonding has performed approximately 1200 debondings, and is skilled at the procedure. 3m unitek has had no prior incidences of a tooth breaking horizontally upon debonding. It is possible that the patient experienced a blow to the mouth that fractured the tooth, but it was kept intact by the bracket and then broke upon debonding. The orthodontist believes that this incident is an anomaly, and is unsure of the cause.
Patient Sequence No: 1, Text Type: N, H10
[58016016]
Patient was at orthodontist to have braces removed at end of treatment. Upon debonding the lower right central anterior bracket, the tooth broke horizontally at the lower gingival 3rd. The patient saw an endodontist, who performed a root canal and placed a temporary crown, then a permanent crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2016-00004 |
| MDR Report Key | 6046138 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-20 |
| Date of Report | 2016-10-08 |
| Date of Event | 2016-09-22 |
| Date Mfgr Received | 2016-10-08 |
| Date Added to Maude | 2016-10-20 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHLEEN BACON |
| Manufacturer Street | 2724 SOUTH PECK RD |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal | 910165097 |
| Manufacturer Phone | 6265744212 |
| Manufacturer G1 | 3M UNITEK CORPORATION |
| Manufacturer Street | 2724 SOUTH PECK RD |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 910165097 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET |
| Generic Name | CERAMIC ORTHODONTIC BRACKET |
| Product Code | NJM |
| Date Received | 2016-10-20 |
| Catalog Number | 4006-250 |
| Lot Number | UNKNOWN |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK CORPORATION |
| Manufacturer Address | 2724 SOUTH PECK RD MONROVIA CA 910165097 US 910165097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-20 |