MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-12-18 for BLAZER-C VERTEBRAL AUGMENTATION SYSTEM BCN3120 manufactured by Benvenue Medical, Inc..
[15127161]
Patient had thoracic (t6) vertebral compression fracture, has been getting chemotherapy, radiation and taking bisphosphonates for cancer treatment. As the surgeon accessed the t6 pedicle with the working cannula, it was apparent that the patient's bone was extremely hard. The surgeon applied quite a bit of force to the cannula while manipulating the cannula to change the direction. As a result of the excessive force, manipulation and torque, the working cannula was bent and eventually broke during the maneuver with 1-2 cm protruding posteriorly from the pedicle but still subcutaneous. The surgeon was still able to inject the bone cement successfully using the blazer-c device completing the vertebral augmentation procedure. The working cannula was cut at the posterior border of the pedicle after further tries to remove it, and a partial piece of the cannula remains securely in the pedicle. The surgeon did not allege a deficiency in the performance of the device and indicates no further patient effect. In the surgeon's opinion, the blazer-c procedure is a clear clinical benefit to the patient. The product has been received for analysis.
Patient Sequence No: 1, Text Type: D, B5
[15339116]
Evaluation summary: the working cannula remnant was returned. Investigation of the returned product was conducted and the reported event was confirmed. Based on the analysis, the breakage was initiated by torsional buckling evident by the "barber pole" shape left on cannula piece. The investigation however could not replicate the reported event in a testing environment. The investigation concluded that the cause of the reported event was due to the use of the access tools exceeded the working cannula torsional strength. In this case the patient presented an unusual demanding hard bone condition, as stated by the surgeon. Review of the device history record confirmed that this device passed all inspection requirements. There were no non-conformances identified for this lot that would have contributed to the reported event. There is no information that indicates evidence of product deficiency. This represents an isolated occurrence; therefore no corrective action will be implemented. Benvenue will continue to monitor these types of incidents and take the necessary steps to correct any future findings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007033608-2014-00004 |
| MDR Report Key | 4377208 |
| Report Source | 05,07 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-11-26 |
| Date of Event | 2014-11-26 |
| Date Mfgr Received | 2014-11-26 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-01-05 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANIL PATEL |
| Manufacturer Street | 3052 BUNKER HILL LANE, SUITE 120 |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal | 95054 |
| Manufacturer Phone | 4084549323 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAZER-C VERTEBRAL AUGMENTATION SYSTEM |
| Product Code | OCJ |
| Date Received | 2014-12-18 |
| Returned To Mfg | 2014-12-05 |
| Catalog Number | BCN3120 |
| Lot Number | 14008001 |
| Device Expiration Date | 2005-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BENVENUE MEDICAL, INC. |
| Manufacturer Address | SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-18 |