MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-29 for KIVA KIVA2200 manufactured by Benvenue Medical.
[5905585]
Kiva spine augmentation coil fatigued (did not maintain its shape) after multiple attempts to deploy into vertebral body (l2).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042956 |
| MDR Report Key | 4825077 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-29 |
| Date of Event | 2015-05-28 |
| Date Added to Maude | 2015-06-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIVA |
| Generic Name | SPINE AUGMENTATION COIL |
| Product Code | OCJ |
| Date Received | 2015-05-29 |
| Model Number | KIVA2200 |
| Lot Number | 15057009 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BENVENUE MEDICAL |
| Manufacturer Address | SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-29 |