MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,07 report with the FDA on 2014-06-10 for JAGUAR CAGE manufactured by Depuy Synthes Spine.
[4595230]
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.
Patient Sequence No: 1, Text Type: D, B5
[11974534]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2014-11602 |
| MDR Report Key | 3863460 |
| Report Source | 03,07 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-05-21 |
| Date Mfgr Received | 2014-05-21 |
| Date Added to Maude | 2014-06-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ANITA BARNICK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283583 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAGUAR CAGE |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2014-06-10 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-10 |