MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-02-08 for APC CLARITY METAL-REINFORCED CERAMIC BRACKET 6500-625,6500-626 manufactured by 3m Unitek.
[240631]
Orthodontist reported that during the debonding of an "apc" clarity ceramic bracket, tooth dentin was exposed when a piece of enamel was removed from a patient's lower right cuspid tooth. Orthodontist stated that he did not use either of the debonding instruments which are listed in the instructions-for-use. Tooth dentin was exposed on the patient's lower left cuspid tooth when patient's dentist used a hish speed diamond burr to remove a remnant ceramic on the tooth. Both teeth were repaired with composit material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2002-00001 |
| MDR Report Key | 376060 |
| Report Source | 05 |
| Date Received | 2002-02-08 |
| Date of Report | 2002-01-16 |
| Date of Event | 2002-01-16 |
| Date Mfgr Received | 2002-01-16 |
| Date Added to Maude | 2002-02-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APC CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Generic Name | ORTHODONTIC CERAMIC BRACKET |
| Product Code | DYW |
| Date Received | 2002-02-08 |
| Model Number | NA |
| Catalog Number | 6500-625,6500-626 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 365150 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | APC CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Baseline Generic Name | ORTHODONTIC CERAMIC BRACKET |
| Baseline Model No | NA |
| Baseline Catalog No | 6500-625,6500-626 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-02-08 |