D
Patient 1
POST MARKET SURVEILLANCE: JAGUAR. CAGE SUBSIDENCE. DOES ALENDRONATE DISTURB THE HEALING PROCESS OF POSTERIOR LUMBAR INTERBODY FUSION? A PROSPECTIVE RANDOMIZED TRIAL (NAGAHAMA, K.) PUBLICATION DATE: APR 2011. N=6 CAGE SUBSIDENCE.
MAUDE MDR 3863460
- MDR report key
- 3863460
- Report number
- 1526439-2014-11602
- Event key
- 0
- Event type
- 3
- Date received
- 2014-06-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- ANITA BARNICK
- Address
- 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
- Phone
- 508-508-5088
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JAGUAR CAGE | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM | DEPUY SYNTHES SPINE | MCV | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-06-10 | 0 | 1. R |
Event Narratives#
N
Patient 1
NO FOLLOW UP REPORT IS ANTICIPATED AS THE PRODUCT HAS NOT BEEN RETURNED. THE SOURCE OF THE REPORT IS THE FOLLOWING LITERATURE SOURCE: ?DOES ALENDRONATE DISTURB THE HEALING PROCESS OF POSTERIOR LUMBAR INTERBODY FUSION? A PROSPECTIVE RANDOMIZED TRIAL (NAGAHAMA, K.) PUBLICATION DATE: APR 2011.? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.