MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-27 for SKIPJACK EXPANDABLE SYSTEM 98-3001 NA manufactured by Seaspine Inc..
| Report Number | 3012120772-2019-00032 |
| MDR Report Key | 9387685 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-10-31 |
| Date Added to Maude | 2019-11-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE CHAVEZ |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7602165109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIPJACK EXPANDABLE SYSTEM |
| Generic Name | INTERVERTEBRAL BODY FUSION DEVICE |
| Product Code | MAX |
| Date Received | 2019-11-27 |
| Model Number | 98-3001 |
| Catalog Number | NA |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEASPINE INC. |
| Manufacturer Address | 5770 ARMADA DRIVE CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-27 |