MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-06 for IRIX 70 * manufactured by Trophy Radioligie.
[617121]
Irix scissor arm broke at knuckle. Notification not given of break until 1. 9. 07.
Patient Sequence No: 1, Text Type: D, B5
[7870564]
The reported condition is attributed to a failure of the support arm. This condition was identified by the mfr in 1995 and corrective actions were instituted. The device cited in this report is involved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020825-2007-00003 |
| MDR Report Key | 845768 |
| Report Source | 05 |
| Date Received | 2007-03-06 |
| Date of Report | 2007-02-13 |
| Date of Event | 2006-12-02 |
| Device Manufacturer Date | 1994-04-01 |
| Date Added to Maude | 2007-05-10 |
| 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 | LINDA SPITZER |
| Manufacturer Street | 1765 THE EXCHANGE |
| Manufacturer City | ATLANTA GA 30339 |
| Manufacturer Country | US |
| Manufacturer Postal | 30339 |
| Manufacturer Phone | 7702263518 |
| Manufacturer G1 | TROPHY RADIOLIGIE |
| Manufacturer Street | 4 RUE F. PELLOUTIE MARNE LA VALLEE |
| Manufacturer City | CROISSY-BEAUBOURG |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1099/1101-5 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRIX 70 |
| Generic Name | DENTAL X-RAY SYSTEM |
| Product Code | EAP |
| Date Received | 2007-03-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 832861 |
| Manufacturer | TROPHY RADIOLIGIE |
| Manufacturer Address | 4 RUE F. PELLOUTIE * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-06 |