MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-08 for * manufactured by Medtronic Neurosurgery.
[2485213]
During craniotomy procedure, it was noted by surgeon that the tip of the medtronic drill had broken off when the bone flap was being cut. Tip was found on dura after bone was removed. Resection of brain tumor continued prior to closure. Portable x-ray was taken and read by neuro radiology. A three way conversation occurred with the radiologist. Closure of brain was decided upon at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2446238 |
| MDR Report Key | 2446238 |
| Date Received | 2012-02-08 |
| Date of Report | 2012-02-08 |
| Date of Event | 2012-01-11 |
| Report Date | 2012-02-08 |
| Date Reported to FDA | 2012-02-08 |
| Date Added to Maude | 2012-02-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | DRILL, SURGICAL |
| Product Code | HBG |
| Date Received | 2012-02-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | P00518797 |
| ID Number | * |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-08 |