MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for BLAZER BCN3120 manufactured by Benvenue Medical, Inc..
[105399932]
Patient Sequence No: 1, Text Type: N, H10
[105399933]
The attending, along with a fellow, were using the blazer-c from benvenue medical in the first lumbar vertebrae of the spine from a left pedicular access. The 11ga diamond tip single step introducer was advanced to the anterior portion of l1 vertebrae married with the 10ga working cannula. The 11ga diamond tip single step introducer was removed and the blazer c augmentation device was deployed. While advancing the blazer c's coil, the knob snapped. The blazer c was removed and the 10ga working cannula was to be removed. However, upon trying to retrieve the cannula, it started to unravel. The beveled tip was left in the l1 vertebral body but most of the cannula was removed. Manufacturer response for blazer c introducer kit, blazer c (per site reporter): do not have follow up from the manufacturer yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7428338 |
| MDR Report Key | 7428338 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-28 |
| Report Date | 2018-03-29 |
| Date Reported to FDA | 2018-03-29 |
| Date Reported to Mfgr | 2018-03-29 |
| Date Added to Maude | 2018-04-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAZER |
| Generic Name | SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY |
| Product Code | OCJ |
| Date Received | 2018-04-13 |
| Returned To Mfg | 2018-03-29 |
| Model Number | BCN3120 |
| Lot Number | 17006002 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BENVENUE MEDICAL, INC. |
| Manufacturer Address | 5403 BETSY ROSS DR SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-13 |