FDA Adverse Event
Injury
Summary report: N
INTELLECT CRANIAL NAVIGATION SOFTWARE
MDR report key: 1171093
·
Received September 19, 2008
Report
- Report Number
- 8010177-2008-00063
- Event Type
- Injury
- Date Received
- September 19, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- STRYKER NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K062640
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. FILES FROM THE CASE HAVE BEEN PROVIDED AND AN INVESTIGATION IS IN PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY REGISTERING THE PT AND THE FIDUCIALS AS THEIR LOCATIONS SHOWED ON THE SCANS WERE NOT MATCHING THE EXPECTED LOCATION ON THE PT. THE SURGEON REPORTED THAT HER ENTRY POINT WAS HIGH - APPROX 4CM SUPERIOR TO THE TUMOR. THE PT EXPERIENCED VENOUS BLEEDING AND REQUIRED A BLOOD TRANSFUSION AS A RESULT. THE INCISION WAS EXTENDED, THE APPROPRIATE ANATOMY WAS FOUND AND THE TUMOR WAS RESECTED. IT WAS REPORTED THAT THE PROCEDURE TOOK APPROX FOUR HOURS LONGER THAN ANTICIPATED. THE SURGEON REPORTED THAT THE CHILD HAS NO NEUROLOGICAL DEFICITS FROM THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLECT CRANIAL NAVIGATION SOFTWARE | STEREOTAXIC INSTRUMENT | HAW | STRYKER NAVIGATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Required Intervention |