MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-11-20 for NONE UNK NA manufactured by Nuvasive, Inc..
[15124113]
Following implantation of a single-level interbody implant and unilateral posterior fixation on (b)(6) 2012, paralysis was reported to have occurred. No specific information related to the chain of events leading up to the injury are known. No specific allegations have been made regarding a product failure that resulted in the injury.
Patient Sequence No: 1, Text Type: D, B5
[15257683]
(b)(4). No device have been returned and no evaluation can be completed. No information about the event or the injury has been received. No further investigation can be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031966-2014-00077 |
| MDR Report Key | 4548707 |
| Report Source | 00 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-20 |
| Date of Event | 2012-10-17 |
| Date Mfgr Received | 2014-10-20 |
| Date Added to Maude | 2015-02-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAUL HOLBROOK |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8583205285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | NONE |
| Product Code | JDN |
| Date Received | 2014-11-20 |
| Model Number | UNK |
| Catalog Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-11-20 |