D
Patient 1
THE DEVICE WAS IMPLANTED 2 YEARS AGO. REPORTEDLY, THE IMPLANT HEAD HAS BECOME SEPARATED FROM THE SHAFT AND THEREFORE A REVISION SURGERY IS REQUIRED. THE REVISION SURGERY HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT.
MAUDE MDR 1059595
- MDR report key
- 1059595
- Report number
- 1037007-2008-00008
- Event key
- 0
- Event type
- 3
- Date received
- 2008-06-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR. DOLAN MILLS
- Address
- 2925 APPLING RD. BARTLETT TN 38133 US
- Phone
- 901-901-9013
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-06-09 | 0 | 1. R |