MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-07-02 for MYSTIQUE ROTH OVATION MANDIBULAR ARCH L1-2 00-412-00 manufactured by Dentsply Gac International, Inc..
[357498]
It was reported that a pt's tooth enamel was damaged when a mystique bracket came loose and debonded. Further investigation of this event revealed that the adhesive was transbond, not a dentsply product, the tooth had been previously restored before the bracket was bonded and improper tooth selection for the bracket size/type.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2418500-2004-00330 |
| MDR Report Key | 532853 |
| Report Source | 05 |
| Date Received | 2004-07-02 |
| Date of Report | 2004-06-04 |
| Date of Event | 2004-06-04 |
| Date Mfgr Received | 2004-06-04 |
| Date Added to Maude | 2004-07-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST., STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | * |
| Manufacturer G1 | TOMY, INC. |
| Manufacturer Street | 818 SHIN-MACHI, OHKUMA-MACHI |
| Manufacturer City | FUTABA-GUN, FUKUSHIMA-KEN 979-1305 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 979-1305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYSTIQUE ROTH OVATION MANDIBULAR ARCH |
| Generic Name | ORTHODONTIC PLASTIC BRACKET |
| Product Code | NJM |
| Date Received | 2004-07-02 |
| Returned To Mfg | 2004-06-23 |
| Model Number | L1-2 |
| Catalog Number | 00-412-00 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 522127 |
| Manufacturer | DENTSPLY GAC INTERNATIONAL, INC. |
| Manufacturer Address | * BOHEMIA NY 11716 US |
| Baseline Brand Name | MYSTIQUE ROTH OVATION MANDIBULAR ARCH |
| Baseline Generic Name | ORTHODONTIC BRACKET |
| Baseline Model No | L1-2 |
| Baseline Catalog No | 00-412-00 |
| Baseline ID | NA |
| Baseline Device Family | MYSTIQUE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K852179 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-07-02 |