MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-29 for CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) 22216-02 19900 manufactured by Brainlab Ag.
| Report Number | 8043933-2019-00061 |
| MDR Report Key | 9391935 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-29 |
| Date of Report | 2019-09-18 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2019-11-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. MARKUS HOFMANN |
| Manufacturer Street | OLOF-PALME-STRASSE 9 |
| Manufacturer City | MUENCHEN, 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal | 81829 |
| Manufacturer G1 | BRAINLAB AG |
| Manufacturer Street | OLOF-PALME-STRASSE 9 |
| Manufacturer City | MUENCHEN, 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81829 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) |
| Generic Name | IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2019-11-29 |
| Model Number | 22216-02 |
| Catalog Number | 19900 |
| Lot Number | SW V. 3.1.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAINLAB AG |
| Manufacturer Address | OLOF-PALME-STRASSE 9 MUENCHEN, 81829 GM 81829 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-11-29 |