MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for UNITEK(TM) MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT 712-050 manufactured by 3m Unitek Corporation.
[29792423]
Adolescent female who started orthodontic treatment in 2014 went to the orthodontist complaining of a toothache on tooth 26 (upper left 1st molar). In order to x-ray the tooth, the molar band was removed. When the band was removed, dental caries (tooth decay) was discovered that affected the tooth's pulp chamber, on the gingival/lingual side of the molar. This was very likely the cause of the patient's toothache. The patient's oral hygiene was described as "medium" by the orthodontist. Dental caries is the result of bacteria-induced breakdown of the hard tissues of the tooth by progressive local demineralization. The cause of the caries was likely a lack of thorough oral hygiene, as plaque can build up around orthodontic appliances. Because the hard tissues of the tooth were broken down by the caries, the removal of the band caused the cavity to appear in the tooth. There is no reason to believe that there was a malfunction of the glass ionomer band cement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2015-00001 |
| MDR Report Key | 5185770 |
| Date Received | 2015-10-28 |
| Date of Report | 2015-09-30 |
| Date of Event | 2015-09-21 |
| Date Mfgr Received | 2015-09-30 |
| Date Added to Maude | 2015-10-28 |
| 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 | 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 | 0 |
| Brand Name | UNITEK(TM) MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT |
| Generic Name | ORTHODONTIC ADHESIVE |
| Product Code | DYH |
| Date Received | 2015-10-28 |
| Catalog Number | 712-050 |
| Lot Number | GF9VB |
| Device Expiration Date | 2016-09-30 |
| 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 | 2015-10-28 |