N
Patient 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION IS UNKNOWN.
MAUDE MDR 7068287
- MDR report key
- 7068287
- Report number
- 0008031020-2017-00674
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-11-17
- Date received
- 2017-11-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. ROSE HAAS
- Address
- 325 CORPORATE DRIVE MAHWAH NJ 07430 US
- Phone
- 201-201-2018
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SILICONE II MCP IMPLANT SIZE 40 (STERILE PACKED) | PROSTHESIS, FINGER, CONSTRAINED, POLYMER | STRYKER GMBH | KYJ | MCP40 | 23758401 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-11-29 | 0 | 1. R |
Event Narratives#
D
Patient 1
ABOLITION OF THE JOINT SPACE AND THE MCP II SILICONE IMPLANT BROKE. PATIENT WILL GO UNDER REVISION SURGERY.