N
Patient 1
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.
MAUDE MDR 6992067
- MDR report key
- 6992067
- Report number
- 0008010177-2017-00271
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-03-21
- Date received
- 2017-10-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 109
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. HANS GEIGER
- Address
- BOETZINGERSTR. 41 FREIBURG D-791
- Phone
- 761-761-7614
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SST EZ SPHERE - 22MM | IMPLANT | STRYKER ORTHOBIOLOGICS-MALVERN | FWP | 80014 | A1604055 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED BY HOSPITAL PHARMACIST THROUGH A COMPANY REPRESENTATIVE THAT A PATIENT DEVELOPED A POSSIBLE POST-SURGICAL INFECTION RELATED TO A MAJOR ORBITAL INFLAMMATORY SYNDROME AFTER A SURGICAL PROCEDURE WITH AN IMPLANT. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY WITHOUT A DELAY. IT WAS REPORTED THE PATIENT RETURNED TO THE HOSPITAL AND ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED.