D
Patient 1
ALL FOUR OF THE SOCKET HEAD CAP SCREWS THAT SECURE THE S7 SUSPENSION SYSTEM CARRIER ARM WITH OPMI PROERGO DENTAL MICROSCOPE TO THE RIGID CEILING COLUMN MOUNT AT THE USER SITE WERE FOUND TO BE LOOSE.
MAUDE MDR 2918802
- MDR report key
- 2918802
- Report number
- 9615010-2013-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-12-18
- Date received
- 2013-01-11
- 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
- JUDY BRIMACOMBE
- Address
- 5160 HACIENDA DRIVE DUBLIN CA 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | S7 CEILING MOUNT/RIGID COLUMN FOR OPMI PROERGO | MICROSCOPE SURGICAL, GENERAL & PLASTIC... | CARL ZEISS MEDITEC AG (OBERKOCHEN SITE) | FSO | S7 CEILING MOUNT | 000000-1103-022 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-01-11 | 0 |
Event Narratives#
N
Patient 1
THE FIELD SERVICE REPRESENTATIVE DISCOVERED THE LOOSE SCREWS DURING A SERVICE VISIT. SHE SUBSEQUENTLY TIGHTENED THE LOOSE SCREWS TO SPECIFICATIONS. SITE CONTACT: (B)(6).