MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-19 for INCOGNITO(TM) 358-111 manufactured by 3m Unitek Corporation.
[38557559]
Patient is described by orthodontist as having a tight bite and there is no doubt he clenches his teeth. The lingual brackets were debonded on (b)(6) 2016 and patient is continuing treatment with a removable orthodontic appliance.
Patient Sequence No: 1, Text Type: N, H10
[38557560]
Adult male in orthodontic treatment using lingual brackets, orthodontist reported a broken tooth, the upper right 1st bicuspid. There was a crown on this tooth. The lingual cusp had sheared off, the buccal portion was left intact. When the patient finishes orthodontic treatment, this tooth will be extracted and replaced with an implant. In speaking with the doctor, she mentioned a prior tooth breakage, the upper left 2nd molar. This tooth also had a crown. The tooth broke off at the gumline and was extracted by an oral surgeon in (b)(6) 2015. This was not reported to the manufacturer at the time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2016-00001 |
| MDR Report Key | 5446874 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-18 |
| Date of Event | 2016-01-20 |
| Date Mfgr Received | 2016-01-20 |
| Device Manufacturer Date | 2015-03-30 |
| Date Added to Maude | 2016-02-19 |
| 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 ROAD |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal | 910165097 |
| Manufacturer Phone | 6265744212 |
| Manufacturer G1 | 3M UNITEK CORPORATION |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| 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 | INCOGNITO(TM) |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | EJF |
| Date Received | 2016-02-19 |
| Catalog Number | 358-111 |
| Operator | DENTIST |
| 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 ROAD MONROVIA CA 910165097 US 910165097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-19 |