MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for 26-1221 manufactured by Codman & Shurtleff, Inc..
[128759918]
The physician was using the midas with the gold perforator hand piece to make a burr hole in the patient's skull. The drill is supposed to stop when it goes through the skull before the dura. The drill did not stop and when the physician sensed the difference stopped. The drill bit was stuck in the skull and would not come out. He had to go around the bit to loosen it and retrieve it from the skull. The drill bit did not penetrate the dura, but patient was sent to mri to ensure there was not a bleed in the epidural space. The patient was then returned to his room in the icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8114742 |
| MDR Report Key | 8114742 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-06 |
| Report Date | 2018-11-16 |
| Date Reported to FDA | 2018-11-16 |
| Date Reported to Mfgr | 2018-11-29 |
| Date Added to Maude | 2018-11-29 |
| 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 | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | DRILLS, BURRS, TREPHINES |
| Product Code | HBG |
| Date Received | 2018-11-29 |
| Catalog Number | 26-1221 |
| Lot Number | HY4750 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-29 |