MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for SURGICASE O-01-0-101000-0011-010 manufactured by Materialise Usa, Llc.
| Report Number | 3005718816-2019-00001 |
| MDR Report Key | 9361713 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-22 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2019-07-07 |
| Date Added to Maude | 2019-11-22 |
| 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 | MS JENNY JONES |
| Manufacturer Street | TECHNOLOGIELAAN 15 |
| Manufacturer City | LEUVEN, VLAAMS BRABANT 3001 |
| Manufacturer Country | BE |
| Manufacturer Postal | 3001 |
| Manufacturer G1 | MATERIALISE USA, LLC |
| Manufacturer Street | 44650 HELM COURT |
| Manufacturer City | PLYMOUTH MI 48170 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48170 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICASE |
| Generic Name | SURGICASE GUIDE |
| Product Code | PBF |
| Date Received | 2019-11-22 |
| Model Number | O-01-0-101000-0011-010 |
| Catalog Number | O-01-0-101000-0011-010 |
| Lot Number | OO19UDEHEZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATERIALISE USA, LLC |
| Manufacturer Address | 44650 HELM COURT PLYMOUTH MI 48170 US 48170 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-22 |