MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-29 for GHAJAR GUIDE 04-0003 manufactured by Neurodynamics, Inc..
[39213415]
Patient Sequence No: 1, Text Type: N, H10
[39213416]
Disposable ghajar guide (which is a drill guide for making an entry hole into the skull with a drill bit) broke while the doctor was drilling, causing the drill bit to advance too far through the skull.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5466013 |
| MDR Report Key | 5466013 |
| Date Received | 2016-02-29 |
| Date of Report | 2016-01-20 |
| Date of Event | 2016-01-12 |
| Report Date | 2016-01-20 |
| Date Reported to FDA | 2016-01-20 |
| Date Reported to Mfgr | 2016-01-20 |
| Date Added to Maude | 2016-02-29 |
| 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 | 0 |
| 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 | GHAJAR GUIDE |
| Generic Name | GUIDE, SURGICAL, INSTRUMENT |
| Product Code | MOF |
| Date Received | 2016-02-29 |
| Model Number | 04-0003 |
| Catalog Number | 04-0003 |
| Lot Number | 5481501 |
| Device Expiration Date | 2016-06-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | NEURODYNAMICS, INC. |
| Manufacturer Address | 524 BROADWAY SUITE 405 NEW YORK NY 10012 US 10012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-29 |