MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,07 report with the FDA on 2014-06-09 for SABER I/F CAGE manufactured by Depuy Synthes Spine.
[15326770]
Post market surveillance review of literature found report of cerebral spinal fluid (csf) leakage involving a saber i/f cage. Article title:? Comparison of unilateral versus bilateral instrumented transforaminal lumbar interbody fusion in degenerative lumbar diseases (xue, h. ) publication date jan 2012.? Clinical findings determined by medical safety and complaint management: n=4, csf leak. The following mfg medwatch reports are being filed for the four patients/events. 1526439-2014-11576, 1526439-2014-11581, 1526439-2014-11582, 1526439-2014-11583.
Patient Sequence No: 1, Text Type: D, B5
[15663824]
No follow up report is anticipated as the product has not been returned. The source of the report is the following literature source:? Comparison of unilateral versus bilateral instrumented transforaminal lumbar interbody fusion in degenerative lumbar diseases (xue, h. ) publication date jan 2012.? 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 | 1526439-2014-11583 |
| MDR Report Key | 3855659 |
| Report Source | 03,07 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-05-21 |
| Date Mfgr Received | 2014-05-21 |
| Date Added to Maude | 2014-06-09 |
| 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 | SABER I/F CAGE |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2014-06-09 |
| 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 | 2014-06-09 |