N
Patient 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
MAUDE MDR 6810387
- MDR report key
- 6810387
- Report number
- 1651501-2017-00036
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-04
- Date received
- 2017-08-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- USER SONIA IRIZARRY
- Address
- 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
- Phone
- 609-609-6099
- 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 MCP SZ 10 | SILICONE MCP | ASCENSION ORTHOPEDICS | KYJ | SMCP-500-10-WW | 152843T | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-22 | 0 | 1. R |
Event Narratives#
D
Patient 1
FOUR OF 4 REPORTS. OTHER MFG REPORT NUMBERS: 1651501-2017-00033,1651501-2017-00034,1651501-2017-00035. IT WAS REPORTED THAT THE INITIAL SILICONE MCP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2016. REVISION CASE WAS SCHEDULED FOR (B)(6) 2017; ONCE THE SURGEON NOTICED THAT THE INDEX FINGER OF THE IMPLANTS HAD FAILED, HE DECIDED TO CHECK ALL OF THE OTHER IMPLANTS (MIDDLE FINGER, RING FINGER, & SMALL FINGER) HAD ALSO FAILED OR ALMOST FAILED. THE INDEX FINGER SILICONE IMPLANT HAD BROKEN AT THE HINGE/DISTAL STEM OF THE SIZE 20 IMPLANT. THIS HAPPENED AS WELL TO THE MIDDLE FINGER SIZE 20 IMPLANT. THE SIZE 10 RING FINGER IMPLANT HAD NOT COMPLETELY FAILED BUT IT HAD A VISIBLE CUT AT THE HINGE/DISTAL STEM SECTION. THE SIZE 10 SMALL FINGER IMPLANT FAILED IN THE SAME FASHION.