D
Patient 1
FOUR SCREWS THAT ATTACH THE TUBEHEAD WERE REPEATEDLY COMING LOOSE.
MAUDE MDR 1083827
- MDR report key
- 1083827
- Report number
- 3004115000-2008-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-07-08
- Date received
- 2008-07-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARI LAMBERT, MGR.
- Address
- 901 WEST OAKTON ST. DES PLAINES IL 60018 US
- Phone
- 847-847-8473
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 765DC INTRAORAL X-RAY | DENTAL X-RAY EQUIPMENT | GENDEX DENTAL SYSTEMS | EAP | 110-0155G1 | A0765DC75 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-07-29 | 0 |
Event Narratives#
N
Patient 1
THERE WAS NO PATIENT OR USER INJURY. RESULTS: THE SCREWS CONNECTING THE TUBEHEAD TO THE YOKE WERE NOT STAYING SECURE. CONCLUSIONS: THE SCISSOR ARM AND TUBEHEAD WILL BE REPLACED UNDER WARRANTY.