MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-16 for PERPOS FCD-2 DEVICE 9062-00 / 9063-00 NA manufactured by Interventional Spine, Inc..
[18532119]
Surgeon reports is doing a removal because he thinks screw is broken.
Patient Sequence No: 1, Text Type: D, B5
[18704173]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2013-00001 |
| MDR Report Key | 3066373 |
| Report Source | 05 |
| Date Received | 2013-04-16 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-04-02 |
| Date Mfgr Received | 2013-04-02 |
| Date Added to Maude | 2013-06-20 |
| 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 Street | 13700 ALTON PARKWAY SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERPOS FCD-2 DEVICE |
| Product Code | MRW |
| Date Received | 2013-04-16 |
| Model Number | 9062-00 / 9063-00 |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-16 |