MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-08 for ZIP INTERSPINOUS FUSION SYSTEM 001-010-S-ZIP manufactured by Aurora Spine, Inc.
[5421401]
The surgeon performed an emergency zip implant on the night of (b)(6) 2014 due to an acute infection. The device was originally implanted on (b)(6) 2014. The implant and graft were sent to pathology for examination. The pt is recovering. At this time, the surgeon does not believe the implant and graft were the causative reason for infection. The surgeon sent a follow-up email on 12/16/2014 stating, "no idea why he got infection but do not see zip as a reasonable cause... Perhaps pt disease... Infections are a risk factor with any surgery... "
Patient Sequence No: 1, Text Type: D, B5
[12855817]
The pathology report was requested, but not received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010326971-2014-00001 |
| MDR Report Key | 4435681 |
| Report Source | 07 |
| Date Received | 2015-01-08 |
| Date of Report | 2015-01-06 |
| Date of Event | 2014-12-08 |
| Date Mfgr Received | 2014-12-09 |
| Date Added to Maude | 2015-01-22 |
| 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 | MIKE THOMPSON, DIR |
| Manufacturer Street | 1920 PALOMAR POINT WAY |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604242004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIP INTERSPINOUS FUSION SYSTEM |
| Generic Name | INTERSPINOUS FUSION DEVICE |
| Product Code | PEK |
| Date Received | 2015-01-08 |
| Model Number | 001-010-S-ZIP |
| Catalog Number | 001-010-S-ZIP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AURORA SPINE, INC |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-08 |