D
Patient 1
GROWTH ROD FRACTURED 11 MONTHS POST-OP.
MAUDE MDR 515665
- MDR report key
- 515665
- Report number
- 2029012-2004-00013
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-02-11
- Date received
- 2004-03-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CAROL BERARD
- Address
- 181 TECHNOLOGY DR IRVINE CA 92618 US
- Phone
- 949-949-9494
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYNERGY SPINAL SYSTEM | ORTHOPEDIC IMPLANT | INTERPORE CROSS INTERNATIONAL | KWO | NA | 7015 | 30476 | K950709 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-03-12 | 0 | 1. H; 2. R |