MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-18 for DAMON CLEAR manufactured by Ormco Corporation.
[18871717]
A doctor's office alleged that alleged that damon clear bracket doors had broken and had caused unanticipated tooth movements during orthodontic treatments on four (4) patients. This is the fifth of five (5) reports.
Patient Sequence No: 1, Text Type: D, B5
[19099208]
Specific information regarding the patient's age, gender, and weight was not provided by the doctor. Although the doctor identified sixteen (16) different damon clear catalog numbers associated with the broken bracket doors, he could not verify which catalog number was used on any of the patients, and no lot numbers were provided for any of the alleged product; therefore, no catalog numbers or lot numbers were identified in this report. The catalog numbers involved in the alleged incidents include: 497-6463, 497-6462, 497-6473, 497-6472, 497-6461, 497-6460, 497-6471, 497-6470, 497-6481, 497-6491, 497-7491, 497-6421, 497-6420, 497-7481, 497-7780, and 497-6480. The doctor reported that he removed the patient's brackets and replaced them with a different product. To date, the patient is doing fine. A visual evaluation was performed on the returned devices, yielding inconclusive results; therefore, the root cause of this incident cannot be identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2013-00112 |
| MDR Report Key | 3473418 |
| Report Source | 05 |
| Date Received | 2013-11-18 |
| Date of Report | 2013-10-17 |
| Date Mfgr Received | 2013-10-17 |
| Date Added to Maude | 2013-11-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAMON CLEAR |
| Generic Name | CERAMIC ORTHODONTIC BRACKET |
| Product Code | NJM |
| Date Received | 2013-11-18 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILLS AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-11-18 |