MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-12 for STRYKER UNIVERSAL FIXATION SYSTEM BPS TRAY BPS 62-50000 manufactured by Stryker.
[362098]
Pt undergoing a left occipital parietal craniotomy for resection of a metastatic brain tumor. Physician was closing the patient's scull when the stryker power screwdriver slipped out of the screw as the physician was placing it. The screwdriver penetrated the skull. Physician removed the other screws that were already in place to examine the dura and found a small violated area of dura. He re-opened the dura to examine the brain. He cauterized small area of brain and closed the dura again. Then he closed the bone flap again and finished the procedure as he normally would. The pt was awakened and transferred to the post anesthesia recovery in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 549290 |
| MDR Report Key | 549290 |
| Date Received | 2004-10-12 |
| Date of Report | 2004-10-11 |
| Date of Event | 2004-10-05 |
| Date Facility Aware | 2004-10-05 |
| Report Date | 2004-10-11 |
| Date Reported to FDA | 2004-10-11 |
| Date Reported to Mfgr | 2004-10-11 |
| Date Added to Maude | 2004-10-20 |
| 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 |
| 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 | STRYKER UNIVERSAL FIXATION SYSTEM BPS TRAY |
| Generic Name | 1.7MM/1.5MM POWER DRIVER |
| Product Code | GXL |
| Date Received | 2004-10-12 |
| Model Number | BPS 62-50000 |
| Catalog Number | BPS 62-50000 |
| Lot Number | 29-15003 CE T11 85 |
| ID Number | 02225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 538780 |
| Manufacturer | STRYKER |
| Manufacturer Address | 4100 MILHAM AVE, KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-10-12 |