N
Patient 1
PATIENT "REPORED" DISC FAILURE, IMMOBILITY AND PAIN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT DEVICE WAS MANUFACTURED TO SPECIFICATION.
MAUDE MDR 8032293
- MDR report key
- 8032293
- Report number
- 3004153240-2018-00243
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-10-01
- Date received
- 2018-11-02
- 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
- THOMAS HAUETER
- Address
- 600 TECHNOLOGY PARK DRIVE BILLERICA MA 01821 US
- Phone
- 781-781-7813
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IFORMA | KNEE INTERPOSITIONAL DEVICE | CONFORMIS, INC. | HSH | M57210600010 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-02 | 0 | 1. R |
Event Narratives#
D
Patient 1
PATIENT "REPORED" DISC FAILURE, IMMOBILITY AND PAIN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.