MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-04-09 for BAXANO NEURAL LOCALIZATION PROBE FG0440-03 manufactured by Baxano, Inc..
[1189633]
During a decompression procedure at the l5/s1 level, the physician withdrew device to reposition. Upon withdrawal, he observed that the distal tip was detached from the neural localization probe. He did lateral and a/p fluoroscopy to visualize the tip and found it just lateral of midline. He successfully retrieved tip without further resection. In the evening, the company spoke to the physician. No additional clinical sequelae was reported as a result of the device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8283024]
The device was inspected. Manufacturing and material records were evaluated and components and processes were within specification. Design is being evaluated and corrective action initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006324586-2009-00004 |
| MDR Report Key | 1429547 |
| Report Source | 07 |
| Date Received | 2009-04-09 |
| Date of Report | 2009-04-08 |
| Date of Event | 2009-03-19 |
| Date Mfgr Received | 2009-03-19 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2009-10-01 |
| 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 | PATTY HEVEY |
| Manufacturer Street | 2660 MARINE WAY, SUITE B |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Manufacturer Phone | 6509371400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAXANO NEURAL LOCALIZATION PROBE |
| Generic Name | NEURAL LOCALIZATION PROBE |
| Product Code | GZI |
| Date Received | 2009-04-09 |
| Catalog Number | FG0440-03 |
| Lot Number | 09031001 |
| Device Expiration Date | 2009-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXANO, INC. |
| Manufacturer Address | 2660 MARINE WAY, SUITE B MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-09 |