MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-06-04 for GX770 INTRAORAL X-RAY 46-404600G6 A0770JT manufactured by Gendex Dental Systems.
[846958]
Articulated arm collapsed, rear pin at inboard arm was broken.
Patient Sequence No: 1, Text Type: D, B5
[8017998]
There was no pt or user injury with this event. The arm of the unit was drifting. Investigation found the rear pin at the inboard arm was broken. The articulating arm has been replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00008 |
| MDR Report Key | 1057995 |
| Report Source | 05,06 |
| Date Received | 2008-06-04 |
| Date of Report | 2008-05-06 |
| Date of Event | 2008-05-02 |
| Date Mfgr Received | 2008-05-06 |
| Device Manufacturer Date | 2007-09-12 |
| Date Added to Maude | 2008-11-10 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT, MGR |
| Manufacturer Street | 901 WEST OAKTON |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643958 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GX770 INTRAORAL X-RAY |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-06-04 |
| Model Number | 46-404600G6 |
| Catalog Number | A0770JT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1268064 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 WEST OAKTON ST. DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-04 |