D
Patient 1
PT ORIGINALLY HAD SURGERY IN 2003. POST-OP X-RAYS INDICATED THAT THE ROD HAD SLIPPED. A SECOND SURGERY WAS REQUIRED IN 2004 TO REPLACE THE RODS AND LOOSE CAP NUTS.
MAUDE MDR 513077
- MDR report key
- 513077
- Report number
- 2029012-2004-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-01-14
- Date received
- 2004-02-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CAROL BERARD
- Address
- 181 TECHNOLOGY DRIVE 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 INTL. | KWO | NA | 6005 | 31293 | K950709 | Y | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-02-25 | 0 | 1. H; 2. R |