N
Patient 1
UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
MAUDE MDR 8625515
- MDR report key
- 8625515
- Report number
- 0008031020-2019-00506
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-04-30
- Date received
- 2019-05-20
- 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. KEVIN SMITH
- 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 | MCP PREFLEX IMPLANT SIZE 40 (STERILE PACKED) | PROSTHESIS, FINGER, CONSTRAINED, POLYMER | STRYKER GMBH | KYJ | MCPX40 | UNKNOWN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-20 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT CAME IN FOR A REVISION OF THEIR MCP REPLACEMENT THAT WAS DONE A FEW MONTHS BACK. UPON EXPLANT, IT WAS IDENTIFIED THAT THE IMPLANT WAS BROKEN. IT WAS FURTHER REPORTED THAT THE IMPLANT WAS REPLACED.