MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-21 for TOFFELMIRE RETAINER 100-0436 * manufactured by Sullivan-schein Dental.
[20139229]
The angled toffelmire retainer has poor quality and erratic machining that caused the matrix band retention slot to inadequately tighten the matrix band and causes metal fatigue and fracture of the retaining element.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035291 |
| MDR Report Key | 596510 |
| Date Received | 2005-04-21 |
| Date of Report | 2005-04-21 |
| Date Added to Maude | 2005-04-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOFFELMIRE RETAINER |
| Generic Name | RETAINER |
| Product Code | JEP |
| Date Received | 2005-04-21 |
| Model Number | 100-0436 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 586319 |
| Manufacturer | SULLIVAN-SCHEIN DENTAL |
| Manufacturer Address | 135 DURYEA RD MELVILLE NY 11747 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-21 |